The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions. - Full Text View

Purpose

The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITY™ stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent. Both stents are mounted on the Raptor® Rapid Exchange Stent Delivery System.

Condition	Intervention	Phase
Coronary Artery Disease	Device: sirolimus-coated Bx Velocity stent Device: uncoated Bx Velocity stent	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	E-Sirius Study: a European, Multi-Center, Randomized, Double-Blind Study of the Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo 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 Cordis Corporation:

Primary Outcome Measures:

In-stent minimum lumen diameter (MLD). [ Time Frame: 8 months. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Composite of MACE defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat TLR. [ Time Frame: 1, 6, 9, and 12 months; 2, 3, 4, 5, 6, 7 and 8 years post procedure. ] [ Designated as safety issue: Yes ]
Angiographic binary restenosis (>=50% diameter stenosis). [ Time Frame: 8 months. ] [ Designated as safety issue: Yes ]
In-lesion MLD. [ Time Frame: 8 months. ] [ Designated as safety issue: Yes ]
Target lesion revascularization. [ Time Frame: 9 months. ] [ Designated as safety issue: Yes ]
Target vessel revascularization. [ Time Frame: 9 months. ] [ Designated as safety issue: Yes ]
Target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization. [ Time Frame: 9 months. ] [ Designated as safety issue: Yes ]
Device success (final residual diameter stenosis of < 50%). [ Time Frame: any time post-procedure. ] [ Designated as safety issue: No ]

Enrollment:	353
Study Start Date:	March 2001
Study Completion Date:	September 2008
Primary Completion Date:	October 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 drug-eluting stent	Device: sirolimus-coated Bx Velocity stent drug-eluting stent
Active Comparator: 2 bare-metal stent	Device: uncoated Bx Velocity stent bare-metal stent

Detailed Description:

This is a multicenter (up to 35 centers), prospective, randomized double blind study. This study has a 2-arm design assessing the safety and effectiveness of the sirolimus-coated Bx VELOCITY stent to the uncoated Bx VELOCITY stent, both mounted on the Raptor Rapid Exchange Stent Delivery System. A total of 350 patients will be entered in the study and will be randomized on a 1:1 basis. Patients will be either randomized to the sirolimus coated or uncoated BX-VELOCITY stent. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4, 5, 6, 7, and 8 years post-procedure, with all patients undergoing repeat angiography at 8 months. Medical resource use during the 5 years follow-up period will be collected and analyzed.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II) OR patients with documented silent ischemia;
Treatment of a single de novo native coronary artery lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment;
Target vessel diameter at the lesion site is >=2.50mm and <=3.0mm in diameter (visual estimate);
Target lesion is >=15mm and <=32mm in length (visual estimate);
Target lesion stenosis is >50% and <100% (visual estimate);

Exclusion Criteria:

Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK >2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
Has unstable angina classified as Braunwald III B or C and A I-II-III, or is having a peri infarction;
Unprotected left main coronary disease with >=50% stenosis;
Significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
Have an ostial target lesion;
Angiographic evidence of thrombus within target lesion;
Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated;
Documented left ventricular ejection fraction <=25%;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235144

Locations

Germany
Herzkatheterlabor und Praxisklinik
Hamburg, Germany
Med. Klinik und Poliklinik
Münster, Germany

Sponsors and Collaborators

Cordis Corporation

Investigators

Principal Investigator:	Joachim Schofer, MD	Herzkatheterlabor und Praxisklinik, Hamburg
Principal Investigator:	Günter Breithardt, MD	Med. Klinik und Poliklinik, Münster

More Information

Publications:

Schampaert E, Moses JW, Schofer J, Schluter M, Gershlick AH, Cohen EA, Palisaitis DA, Breithardt G, Donohoe DJ, Wang H, Popma JJ, Kuntz RE, Leon MB; SIRIUS, E- and C-SIRIUS Investigators. Sirolimus-eluting stents at two years: a pooled analysis of SIRIUS, E-SIRIUS, and C-SIRIUS with emphasis on late revascularizations and stent thromboses. Am J Cardiol. 2006 Jul 1;98(1):36-41. Epub 2006 May 4.

Schluter M, Schofer J, Gershlick AH, Schampaert E, Wijns W, Breithardt G; E- and C-SIRIUS Investigators. Direct stenting of native de novo coronary artery lesions with the sirolimus-eluting stent: a post hoc subanalysis of the pooled E- and C-SIRIUS trials. J Am Coll Cardiol. 2005 Jan 4;45(1):10-3.

Schofer J, Schluter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, Breithardt G; E-SIRIUS Investigators. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet. 2003 Oct 4;362(9390):1093-9.

Hoffmann R, Morice MC, Moses JW, Fitzgerald P, Mauri L, Breithardt G, Schofer J, Serruys P, Stoll HP, Leon M. Impact of Late Incomplete Stent Apposition After Sirolimus-Eluting Stent Implantation on 4-Year Clinical Events. Intravascular Ultrasound Analysis from the Multicenter, Randomized, RAVEL, E-SIRIUS and SIRIUS Trials. Heart. 2007 Aug 29; [Epub ahead of print]

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

Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med. 2007 Mar 8;356(10):989-97. Epub 2007 Feb 12.

Responsible Party:	Dr. Hans-Peter Stoll, Cordis
ClinicalTrials.gov Identifier:	NCT00235144 History of Changes
Other Study ID Numbers:	EC00-07
Study First Received:	October 4, 2005
Last Updated:	May 8, 2009
Health Authority:	Germany: Ethics Commission

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus

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

ClinicalTrials.gov processed this record on May 23, 2013

The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions. (E-SIRIUS)