Coronary DiseaseNCT03194711
BVS-OCT Imaging Study
An observational study of Coronary Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The single center retrospective study evaluates the acute and long term outcomes of bioabsorbable drug-eluting scaffolds (BVS) implantation in 50 consecutive coronary artery disease (CAD) patients using optical coherence tomography (OCT) imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- BVS implantation
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2017to 17 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mount Sinai Catheterization laboratory patients who who underwent PCI with BVS implantation and OCT imaging for treatment of CAD
Who may be able to join
- Consecutive patients who underwent PCI with BVS implantation and OCT imaging for treatment of CAD
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Bioabsorbable Drug-eluting Scaffolds (BVS)-Optical Coherence Tomography (OCT) Imaging Study
The single center retrospective study evaluates the acute and long term outcomes of bioabsorbable drug-eluting scaffolds (BVS) implantation in 50 consecutive coronary artery disease (CAD) patients using optical coherence tomography (OCT) imaging.
Read the detailed description
- INTRODUCTION Bioabsorbable drug-eluting scaffolds ("BVS") have emerged as a potential major breakthrough for treatment of coronary artery lesions providing a possibility to overcome the long term limitations of conventional stent implantation which precludes future surgical revascularization, eliminates reactive vasomotion, impairs noninvasive imaging and exposes patients to the risk of very late stent thrombosis. BVS have been extensively studied in clinical trials. Treatment of noncomplex obstructive coronary artery disease with BVS was within the prespecified margin for noninferiority compared to Xience stent with respect to target lesion failure at 1 year in the latest large-scale randomized trial (ABRORB III). Although the concept of self-degrading stent is attractive and the results from clinical trials have been promising, there is a paucity of data regarding the use of BVS in "real world" patients undergoing percutaneous intervention ("PCI"). The outcomes from a large BVS registry of patients with relatively unselected clinical characteristics and lesions were comparable to those reported for the second generation drug eluting stents ("DES"), however, the scaffold thrombosis rate in the first 30 days after implantation resembled that of the first generation DES suggesting that the lesion selection and procedure optimization require further improvement. BVS development has required new imaging modalities, assessment methodologies, and treatment strategies because their design, degradation rate, coating, changes in mechanical properties may affect safety and efficacy of the device. Due to its high resolution, Optical Coherence Tomography ("OCT") imaging has played a central role in understanding the short and long term performance of bioresorbable scaffolds.
II. STUDY AIM To evaluate the acute and long term outcomes of BVS implantation in consecutive coronary artery disease ("CAD") patients using OCT imaging.
III. STUDY POPULATION Fifty (50) consecutive patients who underwent PCI with BVS implantation and OCT imaging for treatment of CAD.
IV. STUDY DESIGN This is a single center retrospective analysis of data collected under the EXEMPT database (GCO# 02-0178) at the Cardiac Catheterization Laboratory at Mt. Sinai Hospital.
- STUDY PROCEDURES Patients with stable CAD who underwent PCI with BVS implantation. Lesions were treated with pre-dilatation using conventional semicompliant or non-compliant balloon. The use of additional devices, cutting balloons or rotablator, were performed at the operator's discretion. The operator made the decision on BVS length and size. First OCT pullback (OCT-PRE) was performed before BVS implantation to analyze lesion stenosis, references, and plaque morphology including the extent and location of calcification. In addition, online co-registration of OCT with coronary angiogram was performed to confirm the correct spatial orientation of OCT findings. The second OCT pullback (OCT - POST) was performed after BVS implantation followed by post-dilatation (20 atm). Angio-OCT co-registration was used to assess acute post-procedural results.
VI. STUDY OUTCOMES
- Acute lumen gain after BVS implantation by quantitative coronary angiography ("QCA") and OCT; effect of coronary calcification on lumen gain, BVS apposition and expansion.
- Review of the clinical follow up data which was collected at 1 month and 12 months after the procedure
VII. IMAGE ANALYSIS
QCA analysis. In each patient, the treated segment (in-scaffold) and the peri-scaffold segment (defined as 5 mm proximal and distal to the scaffold edge) will be analyzed by QCA in paired matched angiographic views before and after procedure using metallic markers at the proximal and distal ends of the device. Minimal lumen diameter (MLD), reference vessel diameter, percentage of area stenosis, and lesion length will be measured by two experienced analysts using dedicated software (QCA-QAngioXA 7.3; Medis) as previously described. Acute lumenal gain will be defined as the difference between MLD immediately after procedure and MLD before BVS implantation. In addition, the presence of angiographic calcification will be assessed. Calcification will be identified by angiography as readily apparent radiopacities within the vascular wall at the site of stenosis and will be classified as none/mild or moderate (radiopacities noted only during the cardiac cycle before contrast injection)/severe (radiopacities visible without cardiac motion before contrast injection usually compromising both sides of the lumen).
OCT lesion analysis will be performed offline at 1-mm interval according to previously validated criteria and as we previously described. The minimal and reference lumen diameter and area will be measured to calculate percent lumen area stenosis. Plaques will be classified as fibrous, lipid, or calcified. For each lipid plaque, the maximal lipid arc will be measured at 1-mm interval and the minimal thickness of the fibrous cap will be assessed. The degree of circumferential extent of calcification will be quantified at 1 mm interval by measuring the maximal calcification arc.
OCT analysis of BVS will be performed at 1-mm interval within the entire stented segment and at 5 mm proximal and distal to the BVS edge. For each cross section analyzed, the area, mean, minimal and maximal diameters of the BVS will be measured automatically with manual corrections if appropriate. The proximal and distal reference vessel area (RVA) will be calculated as the mean of the largest two lumenal areas 5 mm distal and proximal to the BVS edge. Acute strut fracture will be suspected if isolated struts are detected lying unopposed in the lumen with no connection to other surrounding stent struts. 3D OCT reconstruction with QAngio OCT RE software (Medis) will be performed to confirm the diagnosis. Incomplete strut apposition (ISA) will be defined as the presence of struts separated from the underlying vessel wall. The percentage of ISA will be calculated as a ratio of malapposed struts number to the total number of struts observed at 1-mm interval. Since abluminal border of the struts can be visualized in BVS, we will assess the ISA area for each frame with malapposed struts. The percentage of Residual Area Stenosis (RAS) will be calculated as: [(1 - (minimal lumen area/RVA))] ×50 ; the eccentricity index as the ratio between the minimal and the maximal diameter. The symmetry index will be defined as (maximal stent diameter - minimal stent diameter)/(maximal stent diameter). OCT analysis will be performed in Mount Sinai Cath Lab Core imaging laboratory.
VIII. PROPENSITY-MATCHED COMPARISON BETWEEN BVS AND DES A retrospective analysis will be performed on 50 study patients who underwent PCI with BVS and consecutive patients who underwent DES implantation in Mount Sinai catheterization laboratory with the comparator sample size of 50. The DES patients will be selected from the Mount Sinai imaging database. Propensity score matching will be performed to reduce the effect of confounding factors in the retrospective study for two groups of patients with different recruitment periods. Multiple logistic regression analysis will include the following variables as covariates: previous MI, previous CABG, CAD family history, history of smoking, dyslipidemia, diabetes mellitus, use of atherectomy device, stent/BVS post-dilatation, stent/BVS diameter and length, maximal calcium arc by OCT and total number of treated vessels.
- Conditions
- Coronary Disease
- Being tested
- BVS implantation
- Keywords
- Percutaneous Coronary Revascularization, Optical Coherence Tomography, Stents, Drug-Eluting
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BVS implantationDevice
BVS implantation using conventional semicompliant or non-compliant balloon
| Study group | Role | What they receive |
|---|---|---|
| Patients with stable CAD | Not described Receives: Device: BVS implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute lumen gain by quantitative coronary angiography (QCA)
Acute lumen gain after BVS implantation by quantitative coronary angiography (QCA)
Measured: 1 year
Acute lumen gain by Optical Coherence Tomography (OCT)
Acute lumen gain after BVS implantation by OCT
Measured: 1 year
Secondary outcomes (1)
Major adverse cardiac events
Major adverse cardiac events, defined as a composite of cardiac death, myocardial infarction, and target lesion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start30 May 2017
- Primary completion17 Apr 2018
- Study completion17 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annapoorna Kini, MD, MRCP, FACC, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194711
- Sponsor's protocol ID
- GCO 16-2757
- Status last verified
- May 2018
- First submitted
- 19 Jun 2017
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mattesini A, Secco GG, Dall'Ara G, Ghione M, Rama-Merchan JC, Lupi A, Viceconte N, Lindsay AC, De Silva R, Foin N, Naganuma T, Valente S, Colombo A, Di Mario C. ABSORB biodegradable stents versus second-generation metal stents: a comparison study of 100 complex lesions treated under OCT guidance. JACC Cardiovasc Interv. 2014 Jul;7(7):741-50. doi: 10.1016/j.jcin.2014.01.165.
PubMed 25060016Serruys PW, Onuma Y, Garcia-Garcia HM, Muramatsu T, van Geuns RJ, de Bruyne B, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Rapoza R, Ormiston JA. Dynamics of vessel wall changes following the implantation of the absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months. EuroIntervention. 2014 Mar 20;9(11):1271-84. doi: 10.4244/EIJV9I11A217.
PubMed 24291783Serruys PW, Chevalier B, Dudek D, Cequier A, Carrie D, Iniguez A, Dominici M, van der Schaaf RJ, Haude M, Wasungu L, Veldhof S, Peng L, Staehr P, Grundeken MJ, Ishibashi Y, Garcia-Garcia HM, Onuma Y. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015 Jan 3;385(9962):43-54. doi: 10.1016/S0140-6736(14)61455-0. Epub 2014 Sep 14.
PubMed 25230593Kimura T, Kozuma K, Tanabe K, Nakamura S, Yamane M, Muramatsu T, Saito S, Yajima J, Hagiwara N, Mitsudo K, Popma JJ, Serruys PW, Onuma Y, Ying S, Cao S, Staehr P, Cheong WF, Kusano H, Stone GW; ABSORB Japan Investigators. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J. 2015 Dec 14;36(47):3332-42. doi: 10.1093/eurheartj/ehv435. Epub 2015 Sep 1.
PubMed 26330419Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, McGreevy R, Zhang Z, Simonton C, Stone GW; ABSORB III Investigators. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med. 2015 Nov 12;373(20):1905-15. doi: 10.1056/NEJMoa1509038. Epub 2015 Oct 12.
PubMed 26457558Capodanno D, Gori T, Nef H, Latib A, Mehilli J, Lesiak M, Caramanno G, Naber C, Di Mario C, Colombo A, Capranzano P, Wiebe J, Araszkiewicz A, Geraci S, Pyxaras S, Mattesini A, Naganuma T, Munzel T, Tamburino C. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention. 2015 Feb;10(10):1144-53. doi: 10.4244/EIJY14M07_11.
PubMed 25042421Garcia-Garcia HM, Serruys PW, Campos CM, Muramatsu T, Nakatani S, Zhang YJ, Onuma Y, Stone GW. Assessing bioresorbable coronary devices: methods and parameters. JACC Cardiovasc Imaging. 2014 Nov;7(11):1130-48. doi: 10.1016/j.jcmg.2014.06.018. Epub 2014 Nov 10.
PubMed 25459595Ormiston JA, Serruys PW, Onuma Y, van Geuns RJ, de Bruyne B, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Rapoza R, Garcia-Garcia HM. First serial assessment at 6 months and 2 years of the second generation of absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study. Circ Cardiovasc Interv. 2012 Oct;5(5):620-32. doi: 10.1161/CIRCINTERVENTIONS.112.971549. Epub 2012 Oct 9.
PubMed 23048057Kini AS, Vengrenyuk Y, Pena J, Motoyama S, Feig JE, Meelu OA, Rajamanickam A, Bhat AM, Panwar S, Baber U, Sharma SK. Optical coherence tomography assessment of the mechanistic effects of rotational and orbital atherectomy in severely calcified coronary lesions. Catheter Cardiovasc Interv. 2015 Nov 15;86(6):1024-32. doi: 10.1002/ccd.26000. Epub 2015 May 11.
PubMed 25964009Kini AS, Motoyama S, Vengrenyuk Y, Feig JE, Pena J, Baber U, Bhat AM, Moreno P, Kovacic JC, Narula J, Sharma SK. Multimodality Intravascular Imaging to Predict Periprocedural Myocardial Infarction During Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2015 Jun;8(7):937-45. doi: 10.1016/j.jcin.2015.03.016.
PubMed 26088511Tearney GJ, Regar E, Akasaka T, Adriaenssens T, Barlis P, Bezerra HG, Bouma B, Bruining N, Cho JM, Chowdhary S, Costa MA, de Silva R, Dijkstra J, Di Mario C, Dudek D, Falk E, Feldman MD, Fitzgerald P, Garcia-Garcia HM, Gonzalo N, Granada JF, Guagliumi G, Holm NR, Honda Y, Ikeno F, Kawasaki M, Kochman J, Koltowski L, Kubo T, Kume T, Kyono H, Lam CC, Lamouche G, Lee DP, Leon MB, Maehara A, Manfrini O, Mintz GS, Mizuno K, Morel MA, Nadkarni S, Okura H, Otake H, Pietrasik A, Prati F, Raber L, Radu MD, Rieber J, Riga M, Rollins A, Rosenberg M, Sirbu V, Serruys PW, Shimada K, Shinke T, Shite J, Siegel E, Sonoda S, Suter M, Takarada S, Tanaka A, Terashima M, Thim T, Uemura S, Ughi GJ, van Beusekom HM, van der Steen AF, van Es GA, van Soest G, Virmani R, Waxman S, Weissman NJ, Weisz G; International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT). Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. J Am Coll Cardiol. 2012 Mar 20;59(12):1058-72. doi: 10.1016/j.jacc.2011.09.079.
PubMed 22421299
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioabsorbable Drug-eluting Scaffolds (BVS)-Optical Coherence Tomography (OCT) Imaging Study
- ClinicalTrials.gov ID
- NCT03194711
- Acronym / sponsor ID
- GCO 16-2757
- Conditions
- Coronary Disease
- Keywords
- Percutaneous Coronary Revascularization, Optical Coherence Tomography, Stents, Drug-Eluting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 30 May 2017 (actual)
- Primary completion
- 17 Apr 2018 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The single center retrospective study evaluates the acute and long term outcomes of bioabsorbable drug-eluting scaffolds (BVS) implantation in 50 consecutive coronary artery disease (CAD) patients using optical coherence tomography (OCT) imaging.
Detailed description
- INTRODUCTION Bioabsorbable drug-eluting scaffolds ("BVS") have emerged as a potential major breakthrough for treatment of coronary artery lesions providing a possibility to overcome the long term limitations of conventional stent implantation which precludes future surgical revascularization, eliminates reactive vasomotion, impairs noninvasive imaging and exposes patients to the risk of very late stent thrombosis. BVS have been extensively studied in clinical trials. Treatment of noncomplex obstructive coronary artery disease with BVS was within the prespecified margin for noninferiority compared to Xience stent with respect to target lesion failure at 1 year in the latest large-scale randomized trial (ABRORB III). Although the concept of self-degrading stent is attractive and the results from clinical trials have been promising, there is a paucity of data regarding the use of BVS in "real world" patients undergoing percutaneous intervention ("PCI"). The outcomes from a large BVS registry of patients with relatively unselected clinical characteristics and lesions were comparable to those reported for the second generation drug eluting stents ("DES"), however, the scaffold thrombosis rate in the first 30 days after implantation resembled that of the first generation DES suggesting that the lesion selection and procedure optimization require further improvement. BVS development has required new imaging modalities, assessment methodologies, and treatment strategies because their design, degradation rate, coating, changes in mechanical properties may affect safety and efficacy of the device. Due to its high resolution, Optical Coherence Tomography ("OCT") imaging has played a central role in understanding the short and long term performance of bioresorbable scaffolds.
II. STUDY AIM To evaluate the acute and long term outcomes of BVS implantation in consecutive coronary artery disease ("CAD") patients using OCT imaging.
III. STUDY POPULATION Fifty (50) consecutive patients who underwent PCI with BVS implantation and OCT imaging for treatment of CAD.
IV. STUDY DESIGN This is a single center retrospective analysis of data collected under the EXEMPT database (GCO# 02-0178) at the Cardiac Catheterization Laboratory at Mt. Sinai Hospital.
- STUDY PROCEDURES Patients with stable CAD who underwent PCI with BVS implantation. Lesions were treated with pre-dilatation using conventional semicompliant or non-compliant balloon. The use of additional devices, cutting balloons or rotablator, were performed at the operator's discretion. The operator made the decision on BVS length and size. First OCT pullback (OCT-PRE) was performed before BVS implantation to analyze lesion stenosis, references, and plaque morphology including the extent and location of calcification. In addition, online co-registration of OCT with coronary angiogram was performed to confirm the correct spatial orientation of OCT findings. The second OCT pullback (OCT - POST) was performed after BVS implantation followed by post-dilatation (20 atm). Angio-OCT co-registration was used to assess acute post-procedural results.
VI. STUDY OUTCOMES
- Acute lumen gain after BVS implantation by quantitative coronary angiography ("QCA") and OCT; effect of coronary calcification on lumen gain, BVS apposition and expansion.
- Review of the clinical follow up data which was collected at 1 month and 12 months after the procedure
VII. IMAGE ANALYSIS
QCA analysis. In each patient, the treated segment (in-scaffold) and the peri-scaffold segment (defined as 5 mm proximal and distal to the scaffold edge) will be analyzed by QCA in paired matched angiographic views before and after procedure using metallic markers at the proximal and distal ends of the device. Minimal lumen diameter (MLD), reference vessel diameter, percentage of area stenosis, and lesion length will be measured by two experienced analysts using dedicated software (QCA-QAngioXA 7.3; Medis) as previously described. Acute lumenal gain will be defined as the difference between MLD immediately after procedure and MLD before BVS implantation. In addition, the presence of angiographic calcification will be assessed. Calcification will be identified by angiography as readily apparent radiopacities within the vascular wall at the site of stenosis and will be classified as none/mild or moderate (radiopacities noted only during the cardiac cycle before contrast injection)/severe (radiopacities visible without cardiac motion before contrast injection usually compromising both sides of the lumen).
OCT lesion analysis will be performed offline at 1-mm interval according to previously validated criteria and as we previously described. The minimal and reference lumen diameter and area will be measured to calculate percent lumen area stenosis. Plaques will be classified as fibrous, lipid, or calcified. For each lipid plaque, the maximal lipid arc will be measured at 1-mm interval and the minimal thickness of the fibrous cap will be assessed. The degree of circumferential extent of calcification will be quantified at 1 mm interval by measuring the maximal calcification arc.
OCT analysis of BVS will be performed at 1-mm interval within the entire stented segment and at 5 mm proximal and distal to the BVS edge. For each cross section analyzed, the area, mean, minimal and maximal diameters of the BVS will be measured automatically with manual corrections if appropriate. The proximal and distal reference vessel area (RVA) will be calculated as the mean of the largest two lumenal areas 5 mm distal and proximal to the BVS edge. Acute strut fracture will be suspected if isolated struts are detected lying unopposed in the lumen with no connection to other surrounding stent struts. 3D OCT reconstruction with QAngio OCT RE software (Medis) will be performed to confirm the diagnosis. Incomplete strut apposition (ISA) will be defined as the presence of struts separated from the underlying vessel wall. The percentage of ISA will be calculated as a ratio of malapposed struts number to the total number of struts observed at 1-mm interval. Since abluminal border of the struts can be visualized in BVS, we will assess the ISA area for each frame with malapposed struts. The percentage of Residual Area Stenosis (RAS) will be calculated as: [(1 - (minimal lumen area/RVA))] ×50 ; the eccentricity index as the ratio between the minimal and the maximal diameter. The symmetry index will be defined as (maximal stent diameter - minimal stent diameter)/(maximal stent diameter). OCT analysis will be performed in Mount Sinai Cath Lab Core imaging laboratory.
VIII. PROPENSITY-MATCHED COMPARISON BETWEEN BVS AND DES A retrospective analysis will be performed on 50 study patients who underwent PCI with BVS and consecutive patients who underwent DES implantation in Mount Sinai catheterization laboratory with the comparator sample size of 50. The DES patients will be selected from the Mount Sinai imaging database. Propensity score matching will be performed to reduce the effect of confounding factors in the retrospective study for two groups of patients with different recruitment periods. Multiple logistic regression analysis will include the following variables as covariates: previous MI, previous CABG, CAD family history, history of smoking, dyslipidemia, diabetes mellitus, use of atherectomy device, stent/BVS post-dilatation, stent/BVS diameter and length, maximal calcium arc by OCT and total number of treated vessels.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with stable CAD | – | Device: BVS implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mount Sinai Catheterization laboratory patients who who underwent PCI with BVS implantation and OCT imaging for treatment of CAD
Key inclusion criteria (1 listed)
- Consecutive patients who underwent PCI with BVS implantation and OCT imaging for treatment of CAD
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| BVS implantationBVS implantation using conventional semicompliant or non-compliant balloon | Device | Patients with stable CAD |
Primary outcome
Acute lumen gain by quantitative coronary angiography (QCA)
Time frame: 1 year
Acute lumen gain after BVS implantation by quantitative coronary angiography (QCA)
Acute lumen gain by Optical Coherence Tomography (OCT)
Time frame: 1 year
Acute lumen gain after BVS implantation by OCT
1 secondary outcome
Major adverse cardiac events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Background: PubMed 25060016Mattesini A, Secco GG, Dall'Ara G, Ghione M, Rama-Merchan JC, Lupi A, Viceconte N, Lindsay AC, De Silva R, Foin N, Naganuma T, Valente S, Colombo A, Di Mario C. ABSORB biodegradable stents versus second-generation metal stents: a comparison study of 100 complex lesions treated under OCT guidance. JACC Cardiovasc Interv. 2014 Jul;7(7):741-50. doi: 10.1016/j.jcin.2014.01.165.
- Background: PubMed 24291783Serruys PW, Onuma Y, Garcia-Garcia HM, Muramatsu T, van Geuns RJ, de Bruyne B, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Rapoza R, Ormiston JA. Dynamics of vessel wall changes following the implantation of the absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months. EuroIntervention. 2014 Mar 20;9(11):1271-84. doi: 10.4244/EIJV9I11A217.
- Background: PubMed 25230593Serruys PW, Chevalier B, Dudek D, Cequier A, Carrie D, Iniguez A, Dominici M, van der Schaaf RJ, Haude M, Wasungu L, Veldhof S, Peng L, Staehr P, Grundeken MJ, Ishibashi Y, Garcia-Garcia HM, Onuma Y. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015 Jan 3;385(9962):43-54. doi: 10.1016/S0140-6736(14)61455-0. Epub 2014 Sep 14.
- Background: PubMed 26330419Kimura T, Kozuma K, Tanabe K, Nakamura S, Yamane M, Muramatsu T, Saito S, Yajima J, Hagiwara N, Mitsudo K, Popma JJ, Serruys PW, Onuma Y, Ying S, Cao S, Staehr P, Cheong WF, Kusano H, Stone GW; ABSORB Japan Investigators. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J. 2015 Dec 14;36(47):3332-42. doi: 10.1093/eurheartj/ehv435. Epub 2015 Sep 1.
- Background: PubMed 26457558Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, McGreevy R, Zhang Z, Simonton C, Stone GW; ABSORB III Investigators. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med. 2015 Nov 12;373(20):1905-15. doi: 10.1056/NEJMoa1509038. Epub 2015 Oct 12.
- Background: PubMed 25042421Capodanno D, Gori T, Nef H, Latib A, Mehilli J, Lesiak M, Caramanno G, Naber C, Di Mario C, Colombo A, Capranzano P, Wiebe J, Araszkiewicz A, Geraci S, Pyxaras S, Mattesini A, Naganuma T, Munzel T, Tamburino C. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention. 2015 Feb;10(10):1144-53. doi: 10.4244/EIJY14M07_11.
- Background: PubMed 25459595Garcia-Garcia HM, Serruys PW, Campos CM, Muramatsu T, Nakatani S, Zhang YJ, Onuma Y, Stone GW. Assessing bioresorbable coronary devices: methods and parameters. JACC Cardiovasc Imaging. 2014 Nov;7(11):1130-48. doi: 10.1016/j.jcmg.2014.06.018. Epub 2014 Nov 10.
- Background: PubMed 23048057Ormiston JA, Serruys PW, Onuma Y, van Geuns RJ, de Bruyne B, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Rapoza R, Garcia-Garcia HM. First serial assessment at 6 months and 2 years of the second generation of absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study. Circ Cardiovasc Interv. 2012 Oct;5(5):620-32. doi: 10.1161/CIRCINTERVENTIONS.112.971549. Epub 2012 Oct 9.
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- Individual participant dataSharing planned: No
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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.
Annapoorna Kini, MD, MRCP, FACC principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 1 inclusion and 1 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 7 May 2018. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute lumen gain by quantitative coronary angiography (QCA) (time frame: 1 year). 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 NCT03194711, which also lists 11 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 7 May 2018.