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ABSORB Clinical Investigation, Cohort A (ABSORB A) Everolimus Eluting Coronary Stent System Clinical Investigation (ABSORB A)

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ClinicalTrials.gov Identifier: NCT00300131
Recruitment Status : Completed
First Posted : March 8, 2006
Last Update Posted : September 13, 2011
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Coronary Disease Coronary Artery Disease Coronary Restenosis Device: Bioabsorbable Everolimus Eluting Coronary Stent

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
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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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Ischemia Driven MACE [ Time Frame: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years; ]
  2. Ischemia driven Target Vessel Failure (TVF) [ Time Frame: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years; ]
  3. Acute success (clinical device and clinical procedure) [ Time Frame: Acute ]
  4. Ischemia Driven Target Lesion Revascularization (TLR) [ Time Frame: at 30, 180, 270 days and 1, 2, 3, 4, 5 years; ]
  5. Ischemia Driven Target Vessel Revascularization (TVR) [ Time Frame: at 30, 180, 270 days and 1, 2, 3, 4, 5 years ]

Secondary Outcome Measures :
  1. In-stent Late Loss(LL) [ Time Frame: at 180 days and 2 years ]
  2. In-segment LL [ Time Frame: at 180 days and 2 years ]
  3. Proximal LL (proximal defined as within 5 mm of tissue proximal to stent placement) [ Time Frame: at 180 days and 2 years ]
  4. Distal LL (distal defined as within 5 mm of tissue distal to stent placement) [ Time Frame: at 180 days and 2 years ]
  5. In-stent and in-segment Angiographic Binary Restenosis (ABR) rate [ Time Frame: at 180 days and 2 years ]
  6. In-stent % Volume Obstruction (VO) [ Time Frame: at 180 days and 2 years ]
  7. Persisting incomplete apposition, late incomplete apposition, aneurysm, thrombus, persisting dissection [ Time Frame: at 180 days and 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with coronary artery disease
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: John Ormiston, MD Auckland City Hospital
Principal Investigator: Patrick Serruys, MD Erasmus University Thorax Center
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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