ABSORB Everolimus Eluting Coronary Stent System First in Man Clinical Investigation - Full Text View

Sponsored by:	Abbott Vascular
Information provided by:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT00300131

Purpose

• Prospective, open-labeled First in Man Clinical Investigation enrolling patients with visually estimated nominal vessel diameter of 3.0 mm and lesion length smaller 8 mm receiving a single 3.0 x 12 mm BVS Everolimus Eluting CSS containing 98 ug everolimus per cm² of surface area.

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

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Bioabsorbable Vascular Solutions (BVS) EECSS First in Man Clinical Investigation: A Clinical Evaluation of the BVS Everolimus Eluting CSS in the Treatment of Patients With Single de Novo Native Coronary Artery Lesions

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:	60
Study Start Date:	March 2006
Estimated Study Completion Date:	July 2011
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

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 µg everolimus 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
Additionally, coronary vasomotion test may be done at 2 years post procedure

2 Patient Cohorts of 30 each. 6 months waiting period between recruitment of first and second cohort.

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300131

Locations

Belgium
Onze-Lieve VrouweZiekenhuis
Aalst, Belgium
Denmark
Skejby Sygehus
Aarhus, Denmark
France
Centre Cardiologie du Nord
St. Denis, France, 93002
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, New Zealand

More Information

Publications of Results:

Tanimoto 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.

Ormiston 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.

Other 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.

[No authors listed] TCT Daily: ABSORB: bioabsorbable coronary stents successfully and safely deployed. J Interv Cardiol. 2007 Feb;20(1):36-7. No abstract available.

Publications indexed to this study:

Tanimoto 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.

Responsible Party:	Abbott Vascular ( Abbott Vascular )
Study ID Numbers:	05-370
Study First Received:	March 7, 2006
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00300131
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

Study placed in the following topic categories:

Everolimus
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Constriction, Pathologic
Ischemia

Arteriosclerosis
Coronary Restenosis
Coronary Stenosis
Thrombosis
Coronary Disease
Coronary Occlusion
Coronary Artery Disease

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Cardiovascular Diseases
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009