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

NCT00300131 | Completed DMC

• 1 other identifier: 05-370
• Study Type: observational
• Target: 30
• Locations: 4 countries
• Sites: 4

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.

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Ischemia Driven MACE

  at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;

• Ischemia driven Target Vessel Failure (TVF)

  at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;

• Acute success (clinical device and clinical procedure)

  Acute

• Ischemia Driven Target Lesion Revascularization (TLR)

  at 30, 180, 270 days and 1, 2, 3, 4, 5 years;

• Ischemia Driven Target Vessel Revascularization (TVR)

  at 30, 180, 270 days and 1, 2, 3, 4, 5 years

Secondary Outcomes (7)

• In-stent Late Loss(LL)

  at 180 days and 2 years

• In-segment LL

  at 180 days and 2 years

• Proximal LL (proximal defined as within 5 mm of tissue proximal to stent placement)

  at 180 days and 2 years

• Distal LL (distal defined as within 5 mm of tissue distal to stent placement)

  at 180 days and 2 years

• In-stent and in-segment Angiographic Binary Restenosis (ABR) rate

  at 180 days and 2 years

Study Arms (1)

1

Bioabsorbable Vascular Solutions (BVS) Everolimus Eluting Coronary Stent System

Device: Bioabsorbable Everolimus Eluting Coronary Stent

Interventions

Bioabsorbable Everolimus Eluting Coronary Stent DEVICE

Bioabsorbable drug eluting stent implantation stent in the treatment of coronary artery disease

Also known as: BVS

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with coronary artery disease

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (4)

Skejby Sygehus

Aarhus, Denmark

Location

Erasmus University Thorax Center

Rotterdam, Netherlands

Location

Auckland City Hospital

Auckland, New Zealand

Location

University Hospital

Krakow, Poland

Location

Related Publications (16)

• 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. doi: 10.1002/ccd.20895.

  PMID: 17139655 BACKGROUND

• TCT Daily: ABSORB: bioabsorbable coronary stents successfully and safely deployed. J Interv Cardiol. 2007 Feb;20(1):36-7. doi: 10.1111/j.1540-8183.2007.00235.x. No abstract available.

  PMID: 17300400 BACKGROUND

• 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. doi: 10.1002/ccd.21136.

  PMID: 17503509 RESULT

• 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. doi: 10.1016/S0140-6736(08)60415-8.

  PMID: 18342684 RESULT

• Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hebert K, Veldhof S, Webster M, Thuesen L, Dudek D. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009 Mar 14;373(9667):897-910. doi: 10.1016/S0140-6736(09)60325-1.

  PMID: 19286089 RESULT

• Garcia-Garcia 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. doi: 10.4244/eijv4i4a77.

  PMID: 19284065 RESULT

• 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. doi: 10.1016/j.jacc.2008.08.024.

  PMID: 18992650 RESULT

• 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. doi: 10.4244/eijv4i2a49.

  PMID: 19110796 RESULT

• Ormiston JA, Serruys PW. Bioabsorbable coronary stents. Circ Cardiovasc Interv. 2009 Jun;2(3):255-60. doi: 10.1161/CIRCINTERVENTIONS.109.859173. No abstract available.

  PMID: 20031723 RESULT

• Macaya C, Moreno R. Bioabsorbable drug-eluting stents: the future of coronary angioplasty? Nat Clin Pract Cardiovasc Med. 2008 Oct;5(10):598-9. doi: 10.1038/ncpcardio1306. Epub 2008 Aug 5.

  PMID: 18679382 RESULT

• Onuma Y, Piazza N, Ormiston JA, Serruys PW. Everolimus-eluting bioabsorbable stent--Abbot Vascular programme. EuroIntervention. 2009 Dec 15;5 Suppl F:F98-F102. doi: 10.4244/EIJV5IFA17. No abstract available.

  PMID: 22100687 RESULT

• Oberhauser JP, Hossainy S, Rapoza RJ. Design principles and performance of bioresorbable polymeric vascular scaffolds. EuroIntervention. 2009 Dec 15;5 Suppl F:F15-22. doi: 10.4244/EIJV5IFA3.

  PMID: 22100671 RESULT

• Onuma Y, Serruys PW, Perkins LE, Okamura T, Gonzalo N, Garcia-Garcia 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. doi: 10.1161/CIRCULATIONAHA.109.921528. Epub 2010 Oct 25.

  PMID: 20975003 RESULT

• Onuma Y, Dudek D, Thuesen L, Webster M, Nieman K, Garcia-Garcia HM, Ormiston JA, Serruys PW. Five-year clinical and functional multislice computed tomography angiographic results after coronary implantation of the fully resorbable polymeric everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB cohort A trial. JACC Cardiovasc Interv. 2013 Oct;6(10):999-1009. doi: 10.1016/j.jcin.2013.05.017.

  PMID: 24156961 DERIVED

• 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. doi: 10.1253/circj.cj-11-1416. Epub 2012 Apr 24.

  PMID: 22531596 DERIVED

• 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. doi: 10.4244/EIJV7I9A168.

  PMID: 21959320 DERIVED

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Restenosis; Vascular Diseases; Myocardial Ischemia; Coronary Stenosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• John Ormiston, MD

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

• Patrick Serruys, MD

  Erasmus University Thorax Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2006
• First Posted: March 8, 2006
• Study Start: March 1, 2006
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 13, 2011

Record last verified: 2011-09

Locations

DK (1); NZ (1); NL (1); PL (1)