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

Coronary Artery Disease Clinical Trial

— ABSORB A  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00300131
• Other study ID #: 05-370
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2006
• Last updated: September 9, 2011
• Start date: March 2006
• Est. completion date: July 2011

Study information

• Verified date: September 2011
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health and Disability Ethics Committees
• Study type: Observational

Clinical Trial 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.

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.

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Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Myocardial Ischemia

Intervention

Device:
• Bioabsorbable Everolimus Eluting Coronary Stent
Bioabsorbable drug eluting stent implantation stent in the treatment of coronary artery disease

Locations

Country	Name	City	State
Denmark	Skejby Sygehus	Aarhus
Netherlands	Erasmus University Thorax Center	Rotterdam
New Zealand	Auckland City Hospital	Auckland
Poland	University Hospital	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Countries where clinical trial is conducted

Denmark,  Netherlands,  New Zealand,  Poland, 

References & Publications (13)

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 — View Citation

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 composi — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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 — View Citation

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 o — View Citation

Ormiston JA, Serruys PW. Bioabsorbable coronary stents. Circ Cardiovasc Interv. 2009 Jun;2(3):255-60. doi: 10.1161/CIRCINTERVENTIONS.109.859173. Review. — View Citation

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. — View Citation

Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hébert K, Veldhof S, Webster M, Thuesen L, Dudek D. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and resu — View Citation

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: — View Citation

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 fro — View Citation

TCT Daily: ABSORB: bioabsorbable coronary stents successfully and safely deployed. J Interv Cardiol. 2007 Feb;20(1):36-7. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemia Driven MACE		at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;	Yes
Primary	Ischemia driven Target Vessel Failure (TVF)		at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;	Yes
Primary	Acute success (clinical device and clinical procedure)		Acute	Yes
Primary	Ischemia Driven Target Lesion Revascularization (TLR)		at 30, 180, 270 days and 1, 2, 3, 4, 5 years;	Yes
Primary	Ischemia Driven Target Vessel Revascularization (TVR)		at 30, 180, 270 days and 1, 2, 3, 4, 5 years	Yes
Secondary	In-stent Late Loss(LL)		at 180 days and 2 years	Yes
Secondary	In-segment LL		at 180 days and 2 years	Yes
Secondary	Proximal LL (proximal defined as within 5 mm of tissue proximal to stent placement)		at 180 days and 2 years	Yes
Secondary	Distal LL (distal defined as within 5 mm of tissue distal to stent placement)		at 180 days and 2 years	Yes
Secondary	In-stent and in-segment Angiographic Binary Restenosis (ABR) rate		at 180 days and 2 years	Yes
Secondary	In-stent % Volume Obstruction (VO)		at 180 days and 2 years	Yes
Secondary	Persisting incomplete apposition, late incomplete apposition, aneurysm, thrombus, persisting dissection		at 180 days and 2 years	Yes