Coronary DiseaseABSORB ANCT00300131
ABSORB Clinical Investigation, Cohort A (ABSORB A) Everolimus Eluting Coronary Stent System Clinical Investigation
An observational study of Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 4 sites in 4 countries.
Trial summary
Prospective, open-labeled First in Man Clinical Investigation enrolling patients with visually estimated nominal vessel diameter of 3.0 mm receiving a single 3.0 x 12 mm or 3.0 x 18 mm BVS EECSS containing 98 microgramme per cm² of surface area. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- What is being tested?
- Bioabsorbable Everolimus Eluting Coronary Stent
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Mar 2006to Jul 2011
- 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: Patients with coronary artery disease
Who may be able to join
- Target lesion must be located in a native epicardial vessel with visually estimated nominal vessel diameter of 3.0 mm
- Target lesion must measure less/equal 8 mm in length by visual estimation for 3.0 x 12 mm, expanded to less/equal 14 mm in length by visual estimation when 3.0 x 18 mm stent is available
- The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of > 50% and < 100% with a TIMI flow of greater/equal 1
- Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done more/equal 90 days prior to or if planned to be done 6 months after the index procedure
- Non-Clinical Investigation, percutaneous intervention for lesions in the target vessel is allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure
Who cannot join
- Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
- Lesion involving a bifurcation greater/equal 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation
- Total occlusion (TIMI flow 0), prior to wire passing
- The target vessel contains visible thrombus
- Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion
- Patient has received brachytherapy in any epicardial vessel (including side branches)
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Bioabsorbable Vascular Solutions First in Man Clinical Investigation: A Clinical Evaluation of the Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With Single de Novo Native Coronary Artery Lesions
Prospective, open-labeled First in Man Clinical Investigation enrolling patients with visually estimated nominal vessel diameter of 3.0 mm receiving a single 3.0 x 12 mm or 3.0 x 18 mm BVS EECSS containing 98 microgramme per cm² of surface area.
Read the detailed description
- Prospective, open-labeled Clinical Investigation enrolling patients with visually estimated nominal vessel diameter of 3.0 mm and lesion length ≥ 8 mm receiving a single 3.0 x 12 mm BVS Everolimus Eluting CSS containing 98 microgramme per cm² of surface area. Lesion length will be expanded to≥ 14 mm in length by visual estimation when 3.0 x 18 mm stent is available.
- Angiographic, Intravascular Ultrasound (IVUS), Intravascular Ultrasound- virtual histology (IVUS-VH) and Palpography follow-up will be carried out in all patients at 180 days and 2 years following the index procedure
- Optical Coherence Tomography (OCT) follow-up at 180 days and 2 years will be carried out in a subset of up to 10 patients in Cohorts A and B respectively who are enrolled in pre-determined clinical site(s)
- Multi-slice Spiral Computed Tomography (MSCT) is an optional procedure which may be carried out at 18 months post procedure and again between 4 and 5 year follow up.
- Additionally, coronary vasomotion test may be done at 2 years post procedure
Single patient Cohort of 30.
Pipeline products. Currently in development at Abbott Vascular. Not available for sale.
- Being tested
- Bioabsorbable Everolimus Eluting Coronary Stent
- Keywords
- Bioabsorbable, Coronary Stent, Everolimus, drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis
- Medical subject headings
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Vascular Diseases, Myocardial Ischemia, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioabsorbable Everolimus Eluting Coronary StentDevice
Also called BVS
Bioabsorbable drug eluting stent implantation stent in the treatment of coronary artery disease
| Study group | Role | What they receive |
|---|---|---|
| 1 | Bioabsorbable Vascular Solutions (BVS) Everolimus Eluting Coronary Stent System Receives: Device: Bioabsorbable Everolimus Eluting Coronary Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemia Driven MACE
Measured: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;
Ischemia driven Target Vessel Failure (TVF)
Measured: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;
Acute success (clinical device and clinical procedure)
Measured: Acute
Ischemia Driven Target Lesion Revascularization (TLR)
Measured: at 30, 180, 270 days and 1, 2, 3, 4, 5 years;
Ischemia Driven Target Vessel Revascularization (TVR)
Measured: at 30, 180, 270 days and 1, 2, 3, 4, 5 years
Secondary outcomes (7)
In-stent Late Loss(LL)
Measured: at 180 days and 2 years
In-segment LL
Measured: at 180 days and 2 years
Proximal LL (proximal defined as within 5 mm of tissue proximal to stent placement)
Measured: at 180 days and 2 years
Distal LL (distal defined as within 5 mm of tissue distal to stent placement)
Measured: at 180 days and 2 years
In-stent and in-segment Angiographic Binary Restenosis (ABR) rate
Measured: at 180 days and 2 years
In-stent % Volume Obstruction (VO)
Measured: at 180 days and 2 years
Persisting incomplete apposition, late incomplete apposition, aneurysm, thrombus, persisting dissection
Measured: at 180 days and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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 Abbott Medical DevicesThe 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Ormiston, MD, Principal investigator, Auckland City HospitalPatrick Serruys, MD, Principal investigator, Erasmus University Thorax Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300131
- Sponsor's protocol ID
- 05-370
- Acronym
- ABSORB A
- Status last verified
- Sep 2011
- First submitted
- 7 Mar 2006
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ormiston JA, Webster MW, Armstrong G. First-in-human implantation of a fully bioabsorbable drug-eluting stent: the BVS poly-L-lactic acid everolimus-eluting coronary stent. Catheter Cardiovasc Interv. 2007 Jan;69(1):128-31. doi: 10.1002/ccd.20895.
PubMed 17139655TCT Daily: ABSORB: bioabsorbable coronary stents successfully and safely deployed. J Interv Cardiol. 2007 Feb;20(1):36-7. doi: 10.1111/j.1540-8183.2007.00235.x. No abstract available.
PubMed 17300400Tanimoto S, Serruys PW, Thuesen L, Dudek D, de Bruyne B, Chevalier B, Ormiston JA. Comparison of in vivo acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: insights from the ABSORB and SPIRIT trials. Catheter Cardiovasc Interv. 2007 Oct 1;70(4):515-23. doi: 10.1002/ccd.21136.
PubMed 17503509Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008 Mar 15;371(9616):899-907. doi: 10.1016/S0140-6736(08)60415-8.
PubMed 18342684Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hebert K, Veldhof S, Webster M, Thuesen L, Dudek D. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009 Mar 14;373(9667):897-910. doi: 10.1016/S0140-6736(09)60325-1.
PubMed 19286089Garcia-Garcia HM, Gonzalo N, Pawar R, Kukreja N, Dudek D, Thuesen L, Ormiston JA, Regar E, Serruys PW. Assessment of the absorption process following bioabsorbable everolimus-eluting stent implantation: temporal changes in strain values and tissue composition using intravascular ultrasound radiofrequency data analysis. A substudy of the ABSORB clinical trial. EuroIntervention. 2009 Jan;4(4):443-8. doi: 10.4244/eijv4i4a77.
PubMed 19284065Tanimoto S, Bruining N, van Domburg RT, Rotger D, Radeva P, Ligthart JM, Serruys PW. Late stent recoil of the bioabsorbable everolimus-eluting coronary stent and its relationship with plaque morphology. J Am Coll Cardiol. 2008 Nov 11;52(20):1616-20. doi: 10.1016/j.jacc.2008.08.024.
PubMed 18992650Bruining N, Tanimoto S, Otsuka M, Weustink A, Ligthart J, de Winter S, van Mieghem C, Nieman K, de Feyter PJ, van Domburg RT, Serruys PW. Quantitative multi-modality imaging analysis of a bioabsorbable poly-L-lactic acid stent design in the acute phase: a comparison between 2- and 3D-QCA, QCU and QMSCT-CA. EuroIntervention. 2008 Aug;4(2):285-91. doi: 10.4244/eijv4i2a49.
PubMed 19110796Ormiston JA, Serruys PW. Bioabsorbable coronary stents. Circ Cardiovasc Interv. 2009 Jun;2(3):255-60. doi: 10.1161/CIRCINTERVENTIONS.109.859173. No abstract available.
PubMed 20031723Macaya C, Moreno R. Bioabsorbable drug-eluting stents: the future of coronary angioplasty? Nat Clin Pract Cardiovasc Med. 2008 Oct;5(10):598-9. doi: 10.1038/ncpcardio1306. Epub 2008 Aug 5.
PubMed 18679382Onuma Y, Piazza N, Ormiston JA, Serruys PW. Everolimus-eluting bioabsorbable stent--Abbot Vascular programme. EuroIntervention. 2009 Dec 15;5 Suppl F:F98-F102. doi: 10.4244/EIJV5IFA17. No abstract available.
PubMed 22100687Oberhauser JP, Hossainy S, Rapoza RJ. Design principles and performance of bioresorbable polymeric vascular scaffolds. EuroIntervention. 2009 Dec 15;5 Suppl F:F15-22. doi: 10.4244/EIJV5IFA3.
PubMed 22100671Onuma Y, Serruys PW, Perkins LE, Okamura T, Gonzalo N, Garcia-Garcia HM, Regar E, Kamberi M, Powers JC, Rapoza R, van Beusekom H, van der Giessen W, Virmani R. Intracoronary optical coherence tomography and histology at 1 month and 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model: an attempt to decipher the human optical coherence tomography images in the ABSORB trial. Circulation. 2010 Nov 30;122(22):2288-300. doi: 10.1161/CIRCULATIONAHA.109.921528. Epub 2010 Oct 25.
PubMed 20975003Onuma Y, Dudek D, Thuesen L, Webster M, Nieman K, Garcia-Garcia HM, Ormiston JA, Serruys PW. Five-year clinical and functional multislice computed tomography angiographic results after coronary implantation of the fully resorbable polymeric everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB cohort A trial. JACC Cardiovasc Interv. 2013 Oct;6(10):999-1009. doi: 10.1016/j.jcin.2013.05.017.
PubMed 24156961Brugaletta S, Gogas BD, Garcia-Garcia HM, Farooq V, Girasis C, Heo JH, van Geuns RJ, de Bruyne B, Dudek D, Koolen J, Smits P, Veldhof S, Rapoza R, Onuma Y, Ormiston J, Serruys PW. Vascular compliance changes of the coronary vessel wall after bioresorbable vascular scaffold implantation in the treated and adjacent segments. Circ J. 2012;76(7):1616-23. doi: 10.1253/circj.cj-11-1416. Epub 2012 Apr 24.
PubMed 22531596
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioabsorbable Vascular Solutions First in Man Clinical Investigation: A Clinical Evaluation of the Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With Single de Novo Native Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT00300131
- Acronym / sponsor ID
- ABSORB A / 05-370
- Keywords
- Bioabsorbable, Coronary Stent, Everolimus, drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 8 Mar 2006 (estimated)
- 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.
Prospective, open-labeled First in Man Clinical Investigation enrolling patients with visually estimated nominal vessel diameter of 3.0 mm receiving a single 3.0 x 12 mm or 3.0 x 18 mm BVS EECSS containing 98 microgramme per cm² of surface area.
Detailed description
- Prospective, open-labeled Clinical Investigation enrolling patients with visually estimated nominal vessel diameter of 3.0 mm and lesion length ≥ 8 mm receiving a single 3.0 x 12 mm BVS Everolimus Eluting CSS containing 98 microgramme per cm² of surface area. Lesion length will be expanded to≥ 14 mm in length by visual estimation when 3.0 x 18 mm stent is available.
- Angiographic, Intravascular Ultrasound (IVUS), Intravascular Ultrasound- virtual histology (IVUS-VH) and Palpography follow-up will be carried out in all patients at 180 days and 2 years following the index procedure
- Optical Coherence Tomography (OCT) follow-up at 180 days and 2 years will be carried out in a subset of up to 10 patients in Cohorts A and B respectively who are enrolled in pre-determined clinical site(s)
- Multi-slice Spiral Computed Tomography (MSCT) is an optional procedure which may be carried out at 18 months post procedure and again between 4 and 5 year follow up.
- Additionally, coronary vasomotion test may be done at 2 years post procedure
Single patient Cohort of 30.
Pipeline products. Currently in development at Abbott Vascular. Not available for sale.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Bioabsorbable Everolimus Eluting Coronary StentBioabsorbable Vascular Solutions (BVS) Everolimus Eluting Coronary Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease
Key inclusion criteria (5 listed)
- Target lesion must be located in a native epicardial vessel with visually estimated nominal vessel diameter of 3.0 mm
- Target lesion must measure less/equal 8 mm in length by visual estimation for 3.0 x 12 mm, expanded to less/equal 14 mm in length by visual estimation when 3.0 x 18 mm stent is available
- The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of > 50% and < 100% with a TIMI flow of greater/equal 1
- Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done more/equal 90 days prior to or if planned to be done 6 months after the index procedure
- Non-Clinical Investigation, percutaneous intervention for lesions in the target vessel is allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure
Key exclusion criteria (6 listed)
- Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
- Lesion involving a bifurcation greater/equal 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation
- Total occlusion (TIMI flow 0), prior to wire passing
- The target vessel contains visible thrombus
- Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion
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 |
|---|---|---|
| Bioabsorbable Everolimus Eluting Coronary StentAlso: BVSBioabsorbable drug eluting stent implantation stent in the treatment of coronary artery disease | Device | 1 |
Primary outcome
Ischemia Driven MACE
Time frame: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;
Ischemia driven Target Vessel Failure (TVF)
Time frame: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;
Acute success (clinical device and clinical procedure)
Time frame: Acute
Ischemia Driven Target Lesion Revascularization (TLR)
Time frame: at 30, 180, 270 days and 1, 2, 3, 4, 5 years;
Ischemia Driven Target Vessel Revascularization (TVR)
Time frame: at 30, 180, 270 days and 1, 2, 3, 4, 5 years
7 secondary outcomes
In-stent Late Loss(LL)
Time frame: at 180 days and 2 years
In-segment LL
Time frame: at 180 days and 2 years
Proximal LL (proximal defined as within 5 mm of tissue proximal to stent placement)
Time frame: at 180 days and 2 years
Distal LL (distal defined as within 5 mm of tissue distal to stent placement)
Time frame: at 180 days and 2 years
In-stent and in-segment Angiographic Binary Restenosis (ABR) rate
Time frame: at 180 days and 2 years
In-stent % Volume Obstruction (VO)
Time frame: at 180 days and 2 years
Persisting incomplete apposition, late incomplete apposition, aneurysm, thrombus, persisting dissection
Time frame: at 180 days and 2 years
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 13 Sep 2011.
- Background: PubMed 17139655Ormiston JA, Webster MW, Armstrong G. First-in-human implantation of a fully bioabsorbable drug-eluting stent: the BVS poly-L-lactic acid everolimus-eluting coronary stent. Catheter Cardiovasc Interv. 2007 Jan;69(1):128-31. doi: 10.1002/ccd.20895.
- Background: PubMed 17300400TCT Daily: ABSORB: bioabsorbable coronary stents successfully and safely deployed. J Interv Cardiol. 2007 Feb;20(1):36-7. doi: 10.1111/j.1540-8183.2007.00235.x. No abstract available.
- Results publication: PubMed 17503509Tanimoto S, Serruys PW, Thuesen L, Dudek D, de Bruyne B, Chevalier B, Ormiston JA. Comparison of in vivo acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: insights from the ABSORB and SPIRIT trials. Catheter Cardiovasc Interv. 2007 Oct 1;70(4):515-23. doi: 10.1002/ccd.21136.
- Results publication: PubMed 18342684Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008 Mar 15;371(9616):899-907. doi: 10.1016/S0140-6736(08)60415-8.
- Results publication: PubMed 19286089Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hebert K, Veldhof S, Webster M, Thuesen L, Dudek D. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009 Mar 14;373(9667):897-910. doi: 10.1016/S0140-6736(09)60325-1.
- Results publication: PubMed 19284065Garcia-Garcia HM, Gonzalo N, Pawar R, Kukreja N, Dudek D, Thuesen L, Ormiston JA, Regar E, Serruys PW. Assessment of the absorption process following bioabsorbable everolimus-eluting stent implantation: temporal changes in strain values and tissue composition using intravascular ultrasound radiofrequency data analysis. A substudy of the ABSORB clinical trial. EuroIntervention. 2009 Jan;4(4):443-8. doi: 10.4244/eijv4i4a77.
- Results publication: PubMed 18992650Tanimoto S, Bruining N, van Domburg RT, Rotger D, Radeva P, Ligthart JM, Serruys PW. Late stent recoil of the bioabsorbable everolimus-eluting coronary stent and its relationship with plaque morphology. J Am Coll Cardiol. 2008 Nov 11;52(20):1616-20. doi: 10.1016/j.jacc.2008.08.024.
- Results publication: PubMed 19110796Bruining N, Tanimoto S, Otsuka M, Weustink A, Ligthart J, de Winter S, van Mieghem C, Nieman K, de Feyter PJ, van Domburg RT, Serruys PW. Quantitative multi-modality imaging analysis of a bioabsorbable poly-L-lactic acid stent design in the acute phase: a comparison between 2- and 3D-QCA, QCU and QMSCT-CA. EuroIntervention. 2008 Aug;4(2):285-91. doi: 10.4244/eijv4i2a49.
- Results publication: PubMed 20031723Ormiston JA, Serruys PW. Bioabsorbable coronary stents. Circ Cardiovasc Interv. 2009 Jun;2(3):255-60. doi: 10.1161/CIRCINTERVENTIONS.109.859173. No abstract available.
- Results publication: PubMed 18679382Macaya C, Moreno R. Bioabsorbable drug-eluting stents: the future of coronary angioplasty? Nat Clin Pract Cardiovasc Med. 2008 Oct;5(10):598-9. doi: 10.1038/ncpcardio1306. Epub 2008 Aug 5.
- Results publication: PubMed 22100687Onuma Y, Piazza N, Ormiston JA, Serruys PW. Everolimus-eluting bioabsorbable stent--Abbot Vascular programme. EuroIntervention. 2009 Dec 15;5 Suppl F:F98-F102. doi: 10.4244/EIJV5IFA17. No abstract available.
- Results publication: PubMed 22100671Oberhauser JP, Hossainy S, Rapoza RJ. Design principles and performance of bioresorbable polymeric vascular scaffolds. EuroIntervention. 2009 Dec 15;5 Suppl F:F15-22. doi: 10.4244/EIJV5IFA3.
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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.
John Ormiston, MD principal investigator
Auckland City Hospital
Patrick Serruys, MD principal investigator
Erasmus University Thorax Center
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 4 sites in 4 countries.
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 5 inclusion and 6 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 13 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Netherlands, New Zealand, Poland. 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?
Ischemia Driven MACE (time frame: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;). The study lists 5 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 NCT00300131, which also lists 16 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 13 Sep 2011.