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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
sirolimus-coated Bx Velocity stent
uncoated Bx Velocity stent
Sponsored by
Cordis Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%;

Sites / Locations

  • Herzkatheterlabor und Praxisklinik
  • Med. Klinik und Poliklinik

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

drug-eluting stent

bare-metal stent

Outcomes

Primary Outcome Measures

In-stent minimum lumen diameter (MLD).

Secondary Outcome Measures

Composite of MACE defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat TLR.
Angiographic binary restenosis (>=50% diameter stenosis).
In-lesion MLD.
Target lesion revascularization.
Target vessel revascularization.
Target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization.
Device success (final residual diameter stenosis of < 50%).

Full Information

First Posted
October 4, 2005
Last Updated
May 8, 2009
Sponsor
Cordis Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00235144
Brief Title
The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions.
Acronym
E-SIRIUS
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cordis Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
353 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
drug-eluting stent
Arm Title
2
Arm Type
Active Comparator
Arm Description
bare-metal stent
Intervention Type
Device
Intervention Name(s)
sirolimus-coated Bx Velocity stent
Intervention Description
drug-eluting stent
Intervention Type
Device
Intervention Name(s)
uncoated Bx Velocity stent
Intervention Description
bare-metal stent
Primary Outcome Measure Information:
Title
In-stent minimum lumen diameter (MLD).
Time Frame
8 months.
Secondary Outcome Measure Information:
Title
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.
Title
Angiographic binary restenosis (>=50% diameter stenosis).
Time Frame
8 months.
Title
In-lesion MLD.
Time Frame
8 months.
Title
Target lesion revascularization.
Time Frame
9 months.
Title
Target vessel revascularization.
Time Frame
9 months.
Title
Target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization.
Time Frame
9 months.
Title
Device success (final residual diameter stenosis of < 50%).
Time Frame
any time post-procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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%;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Schofer, MD
Organizational Affiliation
Herzkatheterlabor und Praxisklinik, Hamburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Günter Breithardt, MD
Organizational Affiliation
Med. Klinik und Poliklinik, Münster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzkatheterlabor und Praxisklinik
City
Hamburg
Country
Germany
Facility Name
Med. Klinik und Poliklinik
City
Münster
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17761505
Citation
Hoffmann R, Morice MC, Moses JW, Fitzgerald PJ, Mauri L, Breithardt G, Schofer J, Serruys PW, Stoll HP, Leon MB. Impact of late incomplete stent apposition after sirolimus-eluting stent implantation on 4-year clinical events: intravascular ultrasound analysis from the multicentre, randomised, RAVEL, E-SIRIUS and SIRIUS trials. Heart. 2008 Mar;94(3):322-8. doi: 10.1136/hrt.2007.120154. Epub 2007 Aug 29.
Results Reference
background
PubMed Identifier
16784917
Citation
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. doi: 10.1016/j.amjcard.2006.01.049. Epub 2006 May 4.
Results Reference
result
PubMed Identifier
15629365
Citation
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. doi: 10.1016/j.jacc.2004.09.046.
Results Reference
result
PubMed Identifier
14550694
Citation
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. doi: 10.1016/S0140-6736(03)14462-5.
Results Reference
result
PubMed Identifier
17296825
Citation
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. doi: 10.1056/NEJMoa066633. Epub 2007 Feb 12.
Results Reference
derived

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

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