Acute Coronary Syndrome (ACS)P2NCT02171065
PROSPECT II & PROSPECT ABSORB - an Integrated Natural History Study and Randomized Trial.
A study testing ABSORB BVS in people with Acute Coronary Syndrome (ACS), run by Uppsala University at 1 site in Sweden.
Trial summary
The present study has two components, an overall prospective observational study using multimodality imaging (PROSPECT II) that will examine the natural history of patients with unstable atherosclerotic coronary artery disease with the specific goal to establish the utility of low-risk intracoronary imaging… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome (ACS)
- What is being tested?
- ABSORB BVS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 902 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2014to May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Troponin positive ACS (STEMI >12 h or NSTEMI) occurring within the prior 4 weeks of enrollment, with symptoms consistent with acute ischemia lasting >10 minutes, intended for angiography and Percutaneous Coronary Intervention (PCI) if appropriate.
- Patient must have one-vessel, two-vessel or three-vessel disease in native coronary arteries requiring PCI.
- Successful PCI
- if one or more eligible lesions are identified which meet all of the following angiographic criteria:
- The lesion is a de novo lesion (may be located in either the target or non-target vessel)
- The lesion has an angiographic diameter stenosis <70%, and is not intended for revascularization based on angiographic criteria and Fractional Flow Reserve/Instantaneous wave-free ratio (FFR/iFR).
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- Note: FFR/iFR should be performed on all noncritical lesions of greater than 40% visually estimated angiographic stenosis that are candidates for the ABSORB substudy.
- The lesion has a site-determined IVUS plaque burden in at least one frame ≥65%. Note: Such a lesion may or may not be angiographically evident; i.e. the visually estimated angiographic diameter stenosis may range between 0% - <70%.
- The reference vessel diameter of an eligible lesion is ≥2.5 mm - ≤4.0 mm (visually estimated) capable of being treated with a 2.5 mm, 3.0 mm, or 3.5 mm diameter BVS.
- The lesion length of an eligible lesion is ≤50 mm (visually estimated), capable of being treated by no more than two BVS (maximum length of each BVS 28 mm), allowing for 2 mm BVS overlap and 2 mm of "normal" reference segment treatment at each edge.
- The lesion must be at least 10 mm from a previously implanted stent/scaffold and an intervening 10 mm segment must not have plaque burden (PB) >50%
- A bifurcation lesion may be enrolled only if the side branch is a) ≤2.5 mm in reference vessel diameter, AND b) has either no lesion requiring treatment, or atherosclerotic disease limited to within 5 mm of its origin from the parent vessel such that the operator believes that the side branch can be successfully treated with balloon angioplasty only (without a stent). If a stent subsequently becomes necessary, only a metallic drug-eluting stent (DES) may be used to treat the side branch with a T-stent technique.
- Randomization must occur immediately after the 3-vessel imaging run in the PROSPECT II protocol. If the patient randomizes to BVS, BVS placement must be performed immediately after randomization.
Who cannot join
- Known estimated creatinine clearance <30 ml/min.
- Cardiogenic shock, decompensated hypotension or heart failure requiring intubation, inotropes, intravenous diuretics or a hemodynamic support device.
- Patient has a known hypersensitivity, allergy or contraindication to any of the following: aspirin, both heparin and bivalirudin, all 3 of clopidogrel, prasugrel and ticagrelor, or to contrast that cannot be adequately pre-medicated.
- Refractory ventricular arrhythmias (e.g. ventricular tachycardia or fibrillation) requiring either intravenous pharmacologic treatment or defibrillation during the index PCI procedure.
- Persistent acute conduction system disease requiring temporary pacemaker insertion during the index PCI procedure.
- Prior Coronary Artery Bypass Graft (CABG) at any time or planned CABG.
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- PCI is required of the left main coronary artery, or a left main stenosis is present with a visually estimated angiographic Diameter Stenosis (DS) of >30%.
- Angiographic evidence of severe calcification and/or marked tortuosity of the target (culprit) or a non-culprit vessel is present that would preclude the feasibility of safe imaging of at least the proximal 6 cm of all vessels.
- The presence of a chronic total occlusion of a major epicardial coronary vessel that is not successfully recanalized during the PCI procedure, and thus would preclude intravascular imaging.
- PROSPECT ABSORB
- The randomized lesion cannot be within 10 mm of a lesion previously treated by PCI .
- The randomized lesion may not be in the left main coronary artery.
- The randomized lesion may not be an ostial Left Anterior Descending Coronary Artery (LAD) or ostial Left Circumflex Coronary Artery (LCX) lesion (defined as within 3 mm of the left main coronary artery).
- The randomized lesion may not be an ostial Right Coronary Artery (RCA) lesion (defined as within 3 mm of the aorto-ostium).
- Angiographic evidence of severe calcification and/or marked tortuosity of the target vessel and/or lesion intended for randomization is present that would make it unlikely that the BVS could be advanced to or across the lesion or be adequately expanded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Prospective Natural History Study Using Multimodality Imaging in Patients With ACS- PROSPECT II (Natural History Study), Combined With a Randomized, Controlled, Intervention Study - PROSPECT ABSORB (Randomized Trial)
The present study has two components, an overall prospective observational study using multimodality imaging (PROSPECT II) that will examine the natural history of patients with unstable atherosclerotic coronary artery disease with the specific goal to establish the utility of low-risk intracoronary imaging modalities, IVUS and NIRS, to identify plaques prone to future rupture and clinical events. The randomized PROSPECT ABSORB substudy will examine whether treatment of vulnerable plaques with the Absorb Bioresorbable vascular scaffold (BVS) plus GDMT safely increases the minimum lumen area (MLA) at 24 months compared with GDMT alone.
The cutoff for inclusion in PROSPECT ABSORB will be a site-determined PB ≥65% (rather than the 70% cutoff identified in the original PROSPECT analysis (Stone et al., New England Journal of Medicine, 2011(5)) to account for an observed tendency for sites to underestimate plaque burden during acute treatment of ACS patients. Nonetheless, in PROSPECT, a core laboratory determined PB ≥65% was also associated with a high (7.0%) rate of major adverse cardiac event (MACE) during 3-year follow-up, a rate which may be reduced with a bioresorbable scaffold.
Read the detailed description
Methodology:
PROSPECT II: Multicenter, prospective, natural history study of troponin positive patients with acute coronary syndromes (ACS) examined with angiography and intended for PCI for the initial culprit lesion(s). Prior to PCI all target lesions (those lesions for which PCI is planned) will be examined (if possible) by IVUS/NIRS. After successful PCI of all flow-limiting lesions determined angiographically and/or by FFR/iFR intended to be treated (termed "culprit lesions," whether responsible for the original ACS or otherwise flow-limiting and requiring PCI for complete revascularization), intravascular ultrasound (IVUS), and intracoronary near infrared spectroscopy (NIRS) will be performed over a 6-10 cm length in all three coronary arteries with a combined IVUS/NIRS catheter. Clinical and register follow-up will identify all new coronary events, the origin of which will be determined by follow-up angiography when clinically indicated. These lesions will be identified and compared to the baseline examination at a central angiographic and IVUS/NIRS core laboratory, and adjudicated to have arisen from either originally treated culprit lesions or untreated "non-culprit lesions." This will allow determination of the baseline patient-related and lesion-related variables in culprit and non-culprit lesions that increase the risk for future unanticipated cardiovascular events.
PROSPECT ABSORB (Randomized Trial): Patients with angiographically non-obstructive lesions that are not intended to undergo PCI based on the current standard of care, and that are site-assessed by IVUS to have plaque burden of ≥65% (which has previously been shown in the first PROSPECT study to identify lesions at high risk of causing future coronary events despite their non-obstructive angiographic appearance) will be randomized (1:1) to treatment with ABSORB BVS + guideline directed medical therapy (GDMT) versus GDMT alone. All such randomized patients will undergo repeat angiography and IVUS/NIRS after 25 months of follow-up.
Patient enrollment and procedure overview:
PROSPECT II: Patients with a troponin positive ACS within the prior 4 weeks (STEMI >12 hours or NSTEMI) in whom coronary angiography is planned will be screened and asked to participate in the study. After informed consent has been obtained and prior to PCI, all target lesions (those lesions for which PCI is planned) will be examined (if possible) by IVUS/NIRS. If the patient is successfully treated with PCI of all intended culprit lesions without major procedural complication(s), all three coronary arteries will be examined with IVUS/NIRS. The IVUS results will be visible (unblinded) to the operator, but the NIRS data will be blinded. The patient will be considered formally enrolled in PROSPECT II only after PCI of all intended target culprit lesions has been successfully completed with no major complication(s), and after the study imaging catheter is passed out of the guide catheter into a coronary artery (n = approximately 900 patients). If a staged procedure is required to achieve revascularization of all intended lesions, the patient will not be enrolled until after the staged procedure has been performed without major procedural complication(s). Once enrolled, IVUS and NIRS will be performed over a 6-10 cm length in all three coronary arteries with a combined IVUS/NIRS catheter to assess both the treated culprit lesion(s) and long segments of the untreated coronary tree. Patient enrollment and 3-vessel IVUS and NIRS imaging may be performed either in the same procedure during which the culprit PCI lesion(s) are treated, or during a subsequent angiographic procedure as long as this occurs within 4 weeks of the initial ACS presentation, and after successful and uncomplicated treatment of all target lesions. If the imaging catheter passed into a coronary artery for imaging a non-culprit segment of the coronary tree and no non-culprit segment imaging data is obtained (e.g. the catheter fails and a second catheter is not used), the patient will be disenrolled (discontinued) from the study, and only be followed up for safety purposes for 30 days.
PROSPECT ABSORB: Patients in whom one or more lesions are identified with (a) an angiographically visually estimated diameter stenosis of <70%; (b) a visually estimated reference vessel diameter (RVD) of 2.5 - 4.0 mm; (c) a visually estimated lesion length ≤50 mm; d) a site determined IVUS PB ≥65%; and (e) is located at least 10 mm from a previous stent and at least 10 mm of intervening segment between the previous stent and the non-culprit lesion does not have PB >50% will be enrolled in the PROSPECT ABSORB trial and randomized 1:1 to treatment with ABSORB BVS + GDMT versus GDMT alone (n = approximately 300 patients, 150 patients in each group). For patients with multiple qualifying lesions, a single lesion will be selected for randomization prior to assignment to BVS + GDMT versus GDMT alone.
Study follow-up:
PROSPECT II (Natural History Study)
Clinical follow-up:
Patients will be followed in the Scandinavian quality registers (eg, SWEDEHEART). Patients will undergo follow-up through register data collection and by calls by study coordinators at 1 month (30 days), 6 months (180 days), 12 months, and 24 months, assessing MACE and safety parameters. MACE will be followed in all patients throughout the whole study period until last patient has been followed for 24 months. Patients will then undergo follow-up through register data collection at yearly intervals starting at 3 years and through 15 years. Additional phone follow-up to patients may also be performed.
PROSPECT ABSORB (Randomized Trial)
Clinical follow-up:
Patients will be followed in the Scandinavian quality registers (eg, SWEDEHEART). Patients will undergo follow-up through register data collection and by calls by study coordinators at 1 month (30 days), 6 months (180 days), 12 months, and 24 months. MACE will be followed in all patients throughout the whole study period until last patient has been followed for 24 months. Patients will then undergo follow-up through register data collection at yearly intervals starting at 3 years and through 15 years, with additional phone follow-up subject to Executive Committee approval.
Angiographic follow-up:
All patients randomized in PROSPECT-ABSORB will undergo routine angiographic and 3-vessel IVUS/NIRS follow-up at 25 months; ie, 1 month after the 24 month telephone follow-up. The 25 month angiogram may be performed within a window of between 24.5 months and 28 months after enrollment.
Note: 25-month angiographic follow-up will not be required in PROSPECT-ABSORB randomized patients who either a) have had scaffold thrombosis or in-scaffold restenosis (DS>50% as determined by the angiographic core laboratory) at any time point prior to 25 months, OR b) have had a repeat angiogram ≥12 months after enrollment and in whom IVUS/NIRS of the randomized target lesion was performed.
- Conditions
- Acute Coronary Syndrome (ACS)
- Being tested
- sham, ABSORB BVS
- Keywords
- NIRS/IVUS, multimodality imaging, PROSPECT
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shamDevice
ABSORB BVSDevice
| Study group | Role | What they receive |
|---|---|---|
| Guideline Directed Medical Therapy | Sham comparator | Guideline Directed Medical Therapy Receives: Device: sham |
| ABSORB BVS + Guideline Directed Medical Therapy | Active comparator | ABSORB BVS + Guideline Directed Medical Therapy Receives: Device: ABSORB BVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospect II: Patient Level Non-culprit Lesion Related Non-Culprit Major Adverse Cardiac Event (NC-MACE) Adjudicated to an Originally Untreated Non-culprit Lesion During the Entire Study Duration
Patient-level rate of non-culprit lesion-related MACE (NC-MACE) evaluated at the longest follow-up available, assessed at the time when the last patient enrolled reaches at least 24 months. NC-MACE is defined as an event arising from an originally untreated NC lesion consisting of the composite of 1) cardiac death, 2) myocardial infarction, 3) unstable angina, or 4) progressive angina or anginal equivalent symptoms either 4a) requiring revascularization by coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), and/or 4b) with angiographic core lab-confirmed rapid lesion progression.(NC-MACE).
Measured: Median follow-up of 3.7 (first quartile, third quartile; 3.0, 4.4) years
Prospect Absorb: The Minimum Luminal Area (MLA) at the Randomized Non-culprit Lesion Site in Patients Treated With the ABSORB BVS + GDMT Compared to GDMT Only Measured at 25 Months
The MLA at the randomized non-culprit lesion site in patients treated with Absorb BVS + GDMT compared to GDMT only as measured at 25 months.
Measured: 25 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary Syndrome (ACS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 902 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices, Infraredx, The Medicines Company
- Responsible party
- Sponsor
- Investigators
- David Erlinge, MD, PhD, Study chair, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171065
- Sponsor's protocol ID
- PROSPECT II & PROSPECT ABSORB
- Acronym
- P2
- Status last verified
- Jul 2021
- First submitted
- 19 Jun 2014
- Last updated
- 10 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Thrane PG, Maeng M, Maehara A, Botker HE, Mintz GS, Kjoller-Hansen L, Engstrom T, Matsumura M, Kotinkaduwa LN, Frobert O, Persson J, Wiseth R, Larsen AI, Jensen LO, Nordrehaug JE, Bleie O, Held C, James SK, Ali ZA, Erlinge D, Stone GW. Nonculprit Vulnerable Plaques and Prognosis in Myocardial Infarction With Versus Without ST-Segment Elevation: A PROSPECT II Substudy. Circulation. 2025 Jun 24;151(25):1767-1779. doi: 10.1161/CIRCULATIONAHA.124.071980. Epub 2025 Jun 23.
PubMed 40549845Erlinge D, Tsimikas S, Maeng M, Maehara A, Larsen AI, Engstrom T, Kjoller-Hansen L, Matsumura M, Ben-Yehuda O, Botker HE, Frobert O, Persson J, Wiseth R, Jensen LO, Nordrehaug JE, Trovik T, Jensen U, Bleie O, Omerovic E, James SK, Rylance R, Sharma T, Ali ZA, Stone GW. Lipoprotein(a), Cholesterol, Triglyceride Levels, and Vulnerable Coronary Plaques: A PROSPECT II Substudy. J Am Coll Cardiol. 2025 Jun 3;85(21):2011-2024. doi: 10.1016/j.jacc.2025.04.013.
PubMed 40436465Frobert O, Stone GW, Larsen AI, Zhou Z, Kotinkaduwa LN, Engstrom T, Kjoller-Hansen L, Maeng M, Matsumura M, Ben-Yehuda O, Botker HE, Persson J, Wiseth R, Jensen LO, Nordrehaug JE, Trovik T, Jensen U, Bleie O, James SK, Ali ZA, Omerovic E, Erlinge D, Maehara A. Relationships of hsCRP to High-Risk Vulnerable Plaque After NSTEMI: Insights From the PROSPECT II Trial. JACC Cardiovasc Interv. 2025 May 26;18(10):1217-1228. doi: 10.1016/j.jcin.2025.01.440. Epub 2025 Apr 23.
PubMed 40272345Arslani K, Engstrom T, Maeng M, Kjoller-Hansen L, Maehara A, Zhou Z, Ben-Yehuda O, Botker HE, Matsumura M, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Jensen LO, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Erlinge D, Stone GW. Association Between Physiological Significance and Vulnerable Plaque Characteristics in Patients With Myocardial Infarction: A Prospect II Substudy. JACC Cardiovasc Imaging. 2025 Jun;18(6):696-706. doi: 10.1016/j.jcmg.2024.11.002. Epub 2025 Feb 24.
PubMed 39998456Kjoller-Hansen L, Maehara A, Kelbaek H, Matsumura M, Maeng M, Engstrom T, Frobert O, Persson J, Wiseth R, Larsen AI, Jensen LO, Nordrehaug JE, Omerovic E, Held C, James S, Mintz GS, Ali ZA, Stone GW, Erlinge D. Impact of Lipidic Plaque on In-Stent and Stent Edge-Related Events After PCI in Myocardial Infarction: A PROSPECT II Substudy. Circ Cardiovasc Interv. 2024 Oct;17(10):e014215. doi: 10.1161/CIRCINTERVENTIONS.124.014215. Epub 2024 Sep 25.
PubMed 39319453Gyldenkerne C, Maeng M, Kjoller-Hansen L, Maehara A, Zhou Z, Ben-Yehuda O, Erik Botker H, Engstrom T, Matsumura M, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Jensen LO, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Rosen HC, Stone GW, Erlinge D. Coronary Artery Lesion Lipid Content and Plaque Burden in Diabetic and Nondiabetic Patients: PROSPECT II. Circulation. 2023 Feb 7;147(6):469-481. doi: 10.1161/CIRCULATIONAHA.122.061983. Epub 2022 Dec 16.
PubMed 36524476Erlinge D, Maehara A, Ben-Yehuda O, Botker HE, Maeng M, Kjoller-Hansen L, Engstrom T, Matsumura M, Crowley A, Dressler O, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Okkels Jensen L, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Muller JE, Stone GW; PROSPECT II Investigators. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Lancet. 2021 Mar 13;397(10278):985-995. doi: 10.1016/S0140-6736(21)00249-X.
PubMed 33714389Stone GW, Maehara A, Ali ZA, Held C, Matsumura M, Kjoller-Hansen L, Botker HE, Maeng M, Engstrom T, Wiseth R, Persson J, Trovik T, Jensen U, James SK, Mintz GS, Dressler O, Crowley A, Ben-Yehuda O, Erlinge D; PROSPECT ABSORB Investigators. Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic Plaque. J Am Coll Cardiol. 2020 Nov 17;76(20):2289-2301. doi: 10.1016/j.jacc.2020.09.547. Epub 2020 Oct 15.
PubMed 33069847
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Prospective Natural History Study Using Multimodality Imaging in Patients With ACS- PROSPECT II (Natural History Study), Combined With a Randomized, Controlled, Intervention Study - PROSPECT ABSORB (Randomized Trial)
- ClinicalTrials.gov ID
- NCT02171065
- Acronym / sponsor ID
- P2 / PROSPECT II & PROSPECT ABSORB
- Conditions
- Acute Coronary Syndrome (ACS)
- Keywords
- NIRS/IVUS, multimodality imaging, PROSPECT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 902 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Abbott Medical Devices, Infraredx, The Medicines Company
- Study start
- Jun 2014 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Posted 10 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study has two components, an overall prospective observational study using multimodality imaging (PROSPECT II) that will examine the natural history of patients with unstable atherosclerotic coronary artery disease with the specific goal to establish the utility of low-risk intracoronary imaging modalities, IVUS and NIRS, to identify plaques prone to future rupture and clinical events. The randomized PROSPECT ABSORB substudy will examine whether treatment of vulnerable plaques with the Absorb Bioresorbable vascular scaffold (BVS) plus GDMT safely increases the minimum lumen area (MLA) at 24 months compared with GDMT alone.
The cutoff for inclusion in PROSPECT ABSORB will be a site-determined PB ≥65% (rather than the 70% cutoff identified in the original PROSPECT analysis (Stone et al., New England Journal of Medicine, 2011(5)) to account for an observed tendency for sites to underestimate plaque burden during acute treatment of ACS patients. Nonetheless, in PROSPECT, a core laboratory determined PB ≥65% was also associated with a high (7.0%) rate of major adverse cardiac event (MACE) during 3-year follow-up, a rate which may be reduced with a bioresorbable scaffold.
Detailed description
Methodology:
PROSPECT II: Multicenter, prospective, natural history study of troponin positive patients with acute coronary syndromes (ACS) examined with angiography and intended for PCI for the initial culprit lesion(s). Prior to PCI all target lesions (those lesions for which PCI is planned) will be examined (if possible) by IVUS/NIRS. After successful PCI of all flow-limiting lesions determined angiographically and/or by FFR/iFR intended to be treated (termed "culprit lesions," whether responsible for the original ACS or otherwise flow-limiting and requiring PCI for complete revascularization), intravascular ultrasound (IVUS), and intracoronary near infrared spectroscopy (NIRS) will be performed over a 6-10 cm length in all three coronary arteries with a combined IVUS/NIRS catheter. Clinical and register follow-up will identify all new coronary events, the origin of which will be determined by follow-up angiography when clinically indicated. These lesions will be identified and compared to the baseline examination at a central angiographic and IVUS/NIRS core laboratory, and adjudicated to have arisen from either originally treated culprit lesions or untreated "non-culprit lesions." This will allow determination of the baseline patient-related and lesion-related variables in culprit and non-culprit lesions that increase the risk for future unanticipated cardiovascular events.
PROSPECT ABSORB (Randomized Trial): Patients with angiographically non-obstructive lesions that are not intended to undergo PCI based on the current standard of care, and that are site-assessed by IVUS to have plaque burden of ≥65% (which has previously been shown in the first PROSPECT study to identify lesions at high risk of causing future coronary events despite their non-obstructive angiographic appearance) will be randomized (1:1) to treatment with ABSORB BVS + guideline directed medical therapy (GDMT) versus GDMT alone. All such randomized patients will undergo repeat angiography and IVUS/NIRS after 25 months of follow-up.
Patient enrollment and procedure overview:
PROSPECT II: Patients with a troponin positive ACS within the prior 4 weeks (STEMI >12 hours or NSTEMI) in whom coronary angiography is planned will be screened and asked to participate in the study. After informed consent has been obtained and prior to PCI, all target lesions (those lesions for which PCI is planned) will be examined (if possible) by IVUS/NIRS. If the patient is successfully treated with PCI of all intended culprit lesions without major procedural complication(s), all three coronary arteries will be examined with IVUS/NIRS. The IVUS results will be visible (unblinded) to the operator, but the NIRS data will be blinded. The patient will be considered formally enrolled in PROSPECT II only after PCI of all intended target culprit lesions has been successfully completed with no major complication(s), and after the study imaging catheter is passed out of the guide catheter into a coronary artery (n = approximately 900 patients). If a staged procedure is required to achieve revascularization of all intended lesions, the patient will not be enrolled until after the staged procedure has been performed without major procedural complication(s). Once enrolled, IVUS and NIRS will be performed over a 6-10 cm length in all three coronary arteries with a combined IVUS/NIRS catheter to assess both the treated culprit lesion(s) and long segments of the untreated coronary tree. Patient enrollment and 3-vessel IVUS and NIRS imaging may be performed either in the same procedure during which the culprit PCI lesion(s) are treated, or during a subsequent angiographic procedure as long as this occurs within 4 weeks of the initial ACS presentation, and after successful and uncomplicated treatment of all target lesions. If the imaging catheter passed into a coronary artery for imaging a non-culprit segment of the coronary tree and no non-culprit segment imaging data is obtained (e.g. the catheter fails and a second catheter is not used), the patient will be disenrolled (discontinued) from the study, and only be followed up for safety purposes for 30 days.
PROSPECT ABSORB: Patients in whom one or more lesions are identified with (a) an angiographically visually estimated diameter stenosis of <70%; (b) a visually estimated reference vessel diameter (RVD) of 2.5 - 4.0 mm; (c) a visually estimated lesion length ≤50 mm; d) a site determined IVUS PB ≥65%; and (e) is located at least 10 mm from a previous stent and at least 10 mm of intervening segment between the previous stent and the non-culprit lesion does not have PB >50% will be enrolled in the PROSPECT ABSORB trial and randomized 1:1 to treatment with ABSORB BVS + GDMT versus GDMT alone (n = approximately 300 patients, 150 patients in each group). For patients with multiple qualifying lesions, a single lesion will be selected for randomization prior to assignment to BVS + GDMT versus GDMT alone.
Study follow-up:
PROSPECT II (Natural History Study)
Clinical follow-up:
Patients will be followed in the Scandinavian quality registers (eg, SWEDEHEART). Patients will undergo follow-up through register data collection and by calls by study coordinators at 1 month (30 days), 6 months (180 days), 12 months, and 24 months, assessing MACE and safety parameters. MACE will be followed in all patients throughout the whole study period until last patient has been followed for 24 months. Patients will then undergo follow-up through register data collection at yearly intervals starting at 3 years and through 15 years. Additional phone follow-up to patients may also be performed.
PROSPECT ABSORB (Randomized Trial)
Clinical follow-up:
Patients will be followed in the Scandinavian quality registers (eg, SWEDEHEART). Patients will undergo follow-up through register data collection and by calls by study coordinators at 1 month (30 days), 6 months (180 days), 12 months, and 24 months. MACE will be followed in all patients throughout the whole study period until last patient has been followed for 24 months. Patients will then undergo follow-up through register data collection at yearly intervals starting at 3 years and through 15 years, with additional phone follow-up subject to Executive Committee approval.
Angiographic follow-up:
All patients randomized in PROSPECT-ABSORB will undergo routine angiographic and 3-vessel IVUS/NIRS follow-up at 25 months; ie, 1 month after the 24 month telephone follow-up. The 25 month angiogram may be performed within a window of between 24.5 months and 28 months after enrollment.
Note: 25-month angiographic follow-up will not be required in PROSPECT-ABSORB randomized patients who either a) have had scaffold thrombosis or in-scaffold restenosis (DS>50% as determined by the angiographic core laboratory) at any time point prior to 25 months, OR b) have had a repeat angiogram ≥12 months after enrollment and in whom IVUS/NIRS of the randomized target lesion was performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guideline Directed Medical Therapy | Sham comparator | Device: shamGuideline Directed Medical Therapy |
| ABSORB BVS + Guideline Directed Medical Therapy | Active comparator | Device: ABSORB BVSABSORB BVS + Guideline Directed Medical Therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Troponin positive ACS (STEMI >12 h or NSTEMI) occurring within the prior 4 weeks of enrollment, with symptoms consistent with acute ischemia lasting >10 minutes, intended for angiography and Percutaneous Coronary Intervention (PCI) if appropriate.
- Patient must have one-vessel, two-vessel or three-vessel disease in native coronary arteries requiring PCI.
- Successful PCI
- if one or more eligible lesions are identified which meet all of the following angiographic criteria:
- The lesion is a de novo lesion (may be located in either the target or non-target vessel)
Key exclusion criteria (15 listed)
- Known estimated creatinine clearance <30 ml/min.
- Cardiogenic shock, decompensated hypotension or heart failure requiring intubation, inotropes, intravenous diuretics or a hemodynamic support device.
- Patient has a known hypersensitivity, allergy or contraindication to any of the following: aspirin, both heparin and bivalirudin, all 3 of clopidogrel, prasugrel and ticagrelor, or to contrast that cannot be adequately pre-medicated.
- Refractory ventricular arrhythmias (e.g. ventricular tachycardia or fibrillation) requiring either intravenous pharmacologic treatment or defibrillation during the index PCI procedure.
- Persistent acute conduction system disease requiring temporary pacemaker insertion during the index PCI procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sham | Device | Guideline Directed Medical Therapy |
| ABSORB BVS | Device | ABSORB BVS + Guideline Directed Medical Therapy |
Primary outcome
Prospect II: Patient Level Non-culprit Lesion Related Non-Culprit Major Adverse Cardiac Event (NC-MACE) Adjudicated to an Originally Untreated Non-culprit Lesion During the Entire Study Duration
Time frame: Median follow-up of 3.7 (first quartile, third quartile; 3.0, 4.4) years
Patient-level rate of non-culprit lesion-related MACE (NC-MACE) evaluated at the longest follow-up available, assessed at the time when the last patient enrolled reaches at least 24 months. NC-MACE is defined as an event arising from an originally untreated NC lesion consisting of the composite of 1) cardiac death, 2) myocardial infarction, 3) unstable angina, or 4) progressive angina or anginal equivalent symptoms either 4a) requiring revascularization by coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), and/or 4b) with angiographic core lab-confirmed rapid lesion progression.(NC-MACE).
Prospect Absorb: The Minimum Luminal Area (MLA) at the Randomized Non-culprit Lesion Site in Patients Treated With the ABSORB BVS + GDMT Compared to GDMT Only Measured at 25 Months
Time frame: 25 month
The MLA at the randomized non-culprit lesion site in patients treated with Absorb BVS + GDMT compared to GDMT only as measured at 25 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40549845Thrane PG, Maeng M, Maehara A, Botker HE, Mintz GS, Kjoller-Hansen L, Engstrom T, Matsumura M, Kotinkaduwa LN, Frobert O, Persson J, Wiseth R, Larsen AI, Jensen LO, Nordrehaug JE, Bleie O, Held C, James SK, Ali ZA, Erlinge D, Stone GW. Nonculprit Vulnerable Plaques and Prognosis in Myocardial Infarction With Versus Without ST-Segment Elevation: A PROSPECT II Substudy. Circulation. 2025 Jun 24;151(25):1767-1779. doi: 10.1161/CIRCULATIONAHA.124.071980. Epub 2025 Jun 23.
- Derived from this study: PubMed 40436465Erlinge D, Tsimikas S, Maeng M, Maehara A, Larsen AI, Engstrom T, Kjoller-Hansen L, Matsumura M, Ben-Yehuda O, Botker HE, Frobert O, Persson J, Wiseth R, Jensen LO, Nordrehaug JE, Trovik T, Jensen U, Bleie O, Omerovic E, James SK, Rylance R, Sharma T, Ali ZA, Stone GW. Lipoprotein(a), Cholesterol, Triglyceride Levels, and Vulnerable Coronary Plaques: A PROSPECT II Substudy. J Am Coll Cardiol. 2025 Jun 3;85(21):2011-2024. doi: 10.1016/j.jacc.2025.04.013.
- Derived from this study: PubMed 40272345Frobert O, Stone GW, Larsen AI, Zhou Z, Kotinkaduwa LN, Engstrom T, Kjoller-Hansen L, Maeng M, Matsumura M, Ben-Yehuda O, Botker HE, Persson J, Wiseth R, Jensen LO, Nordrehaug JE, Trovik T, Jensen U, Bleie O, James SK, Ali ZA, Omerovic E, Erlinge D, Maehara A. Relationships of hsCRP to High-Risk Vulnerable Plaque After NSTEMI: Insights From the PROSPECT II Trial. JACC Cardiovasc Interv. 2025 May 26;18(10):1217-1228. doi: 10.1016/j.jcin.2025.01.440. Epub 2025 Apr 23.
- Derived from this study: PubMed 39998456Arslani K, Engstrom T, Maeng M, Kjoller-Hansen L, Maehara A, Zhou Z, Ben-Yehuda O, Botker HE, Matsumura M, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Jensen LO, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Erlinge D, Stone GW. Association Between Physiological Significance and Vulnerable Plaque Characteristics in Patients With Myocardial Infarction: A Prospect II Substudy. JACC Cardiovasc Imaging. 2025 Jun;18(6):696-706. doi: 10.1016/j.jcmg.2024.11.002. Epub 2025 Feb 24.
- Derived from this study: PubMed 39319453Kjoller-Hansen L, Maehara A, Kelbaek H, Matsumura M, Maeng M, Engstrom T, Frobert O, Persson J, Wiseth R, Larsen AI, Jensen LO, Nordrehaug JE, Omerovic E, Held C, James S, Mintz GS, Ali ZA, Stone GW, Erlinge D. Impact of Lipidic Plaque on In-Stent and Stent Edge-Related Events After PCI in Myocardial Infarction: A PROSPECT II Substudy. Circ Cardiovasc Interv. 2024 Oct;17(10):e014215. doi: 10.1161/CIRCINTERVENTIONS.124.014215. Epub 2024 Sep 25.
- Derived from this study: PubMed 36524476Gyldenkerne C, Maeng M, Kjoller-Hansen L, Maehara A, Zhou Z, Ben-Yehuda O, Erik Botker H, Engstrom T, Matsumura M, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Jensen LO, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Rosen HC, Stone GW, Erlinge D. Coronary Artery Lesion Lipid Content and Plaque Burden in Diabetic and Nondiabetic Patients: PROSPECT II. Circulation. 2023 Feb 7;147(6):469-481. doi: 10.1161/CIRCULATIONAHA.122.061983. Epub 2022 Dec 16.
- Derived from this study: PubMed 33714389Erlinge D, Maehara A, Ben-Yehuda O, Botker HE, Maeng M, Kjoller-Hansen L, Engstrom T, Matsumura M, Crowley A, Dressler O, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Okkels Jensen L, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Muller JE, Stone GW; PROSPECT II Investigators. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Lancet. 2021 Mar 13;397(10278):985-995. doi: 10.1016/S0140-6736(21)00249-X.
- Derived from this study: PubMed 33069847Stone GW, Maehara A, Ali ZA, Held C, Matsumura M, Kjoller-Hansen L, Botker HE, Maeng M, Engstrom T, Wiseth R, Persson J, Trovik T, Jensen U, James SK, Mintz GS, Dressler O, Crowley A, Ben-Yehuda O, Erlinge D; PROSPECT ABSORB Investigators. Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic Plaque. J Am Coll Cardiol. 2020 Nov 17;76(20):2289-2301. doi: 10.1016/j.jacc.2020.09.547. Epub 2020 Oct 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Erlinge, MD, PhD study chair
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABSORB BVS in people with Acute Coronary Syndrome (ACS), run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospect II: Patient Level Non-culprit Lesion Related Non-Culprit Major Adverse Cardiac Event (NC-MACE) Adjudicated to an Originally Untreated Non-culprit Lesion During the Entire Study Duration (time frame: Median follow-up of 3.7 (first quartile, third quartile; 3.0, 4.4) years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02171065, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.