ABSORB Clinical Investigation, Cohort A (ABSORB A) Everolimus Eluting Coronary Stent System Clinical Investigation (ABSORB A)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00300131 |
Recruitment Status
:
Completed
First Posted
: March 8, 2006
Last Update Posted
: September 13, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Coronary Disease Coronary Artery Disease Coronary Restenosis | Device: Bioabsorbable Everolimus Eluting Coronary Stent |
- 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 Type : | Observational |
Actual Enrollment : | 30 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
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 |
Study Start Date : | March 2006 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | July 2011 |
Group/Cohort | Intervention/treatment |
---|---|
1
Bioabsorbable Vascular Solutions (BVS) Everolimus Eluting Coronary Stent System
|
Device: Bioabsorbable Everolimus Eluting Coronary Stent
Bioabsorbable drug eluting stent implantation stent in the treatment of coronary artery disease
Other Name: BVS
|
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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
Exclusion Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00300131
Denmark | |
Skejby Sygehus | |
Aarhus, Denmark | |
Netherlands | |
Erasmus University Thorax Center | |
Rotterdam, Netherlands | |
New Zealand | |
Auckland City Hospital | |
Auckland, New Zealand | |
Poland | |
University Hospital | |
Krakow, Poland |
Principal Investigator: | John Ormiston, MD | Auckland City Hospital | |
Principal Investigator: | Patrick Serruys, MD | Erasmus University Thorax Center |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Abbott Vascular |
ClinicalTrials.gov Identifier: | NCT00300131 History of Changes |
Other Study ID Numbers: |
05-370 |
First Posted: | March 8, 2006 Key Record Dates |
Last Update Posted: | September 13, 2011 |
Last Verified: | September 2011 |
Keywords provided by Abbott Vascular:
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 |
Additional relevant MeSH terms:
Coronary Artery Disease Myocardial Ischemia Coronary Disease Coronary Restenosis Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Coronary Stenosis |
Everolimus Sirolimus Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents |