ABSORB Clinical Investigation, Cohort A (ABSORB A) Everolimus Eluting Coronary Stent System Clinical Investigation - Full Text View

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:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Sirolimus Everolimus Temsirolimus

U.S. FDA Resources

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

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:

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.

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

García-García 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.

Bruining 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.

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.

Onuma Y, Serruys PW, Perkins LE, Okamura T, Gonzalo N, García-García 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. Epub 2010 Oct 25.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Brugaletta 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. Epub 2012 Apr 24.

Dudek D, Onuma Y, Ormiston JA, Thuesen L, Miquel-Hebert K, Serruys PW. Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2012 Jan;7(9):1060-1.

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
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
Myocardial Ischemia
Coronary Disease
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Stenosis
Everolimus

Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 19, 2013