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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00300131
First received: March 7, 2006
Last updated: September 9, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Device: Bioabsorbable Everolimus Eluting Coronary Stent
Phase 3

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

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

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

Enrollment: 30
Study Start Date: March 2006
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:
Patrick W Serruys, John A Ormiston, Yoshinobu Onuma, Evelyn Regar, Nieves Gonzalo, Hector M Garcia-Garcia, Koen Nieman, Nico Bruining, Cecile Dorange, Karine Miquel-Hebert, Susan Veldhof, Mark Webster, Leif Thuesen, Dariusz Dudek, A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods, The Lancet, Volume 373, Issue 9667, 14 March 2009-20 March 2009, Pages 897-910, ISSN 0140-6736
Ormiston,John A. and Patrick W.S. Serruys. Bioabsorbable Coronary Stents. Circ Cardiovasc Intervent 2009;2;255-260
Onuma, Yshinobu MD., et.al. Everolimus-eluting bioabsorbable stent-Abbott Vascular programme. EuroIntervention Supplement (2009) Vol. 5 (Supplement F) F98-F102.
Oberhauser, James, PhD., et.al. Design Principles and Performance of Bioresorbable Polymeric Vascular Scaffolds. EuroIntervention Supplement (2009) Vol. 5 (Supplement F) F15-F22.

Additional 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
Study First Received: March 7, 2006
Last Updated: September 9, 2011
Health Authority: New Zealand: Health and Disability Ethics Committees

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
Coronary Disease
Coronary Restenosis
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Stenosis
Heart Diseases
Vascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014