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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00235144
First received: October 4, 2005
Last updated: May 8, 2009
Last verified: May 2009
  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:


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:

  1. 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;
  2. 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;
  3. Target vessel diameter at the lesion site is >=2.50mm and <=3.0mm in diameter (visual estimate);
  4. Target lesion is >=15mm and <=32mm in length (visual estimate);
  5. Target lesion stenosis is >50% and <100% (visual estimate);

Exclusion Criteria:

  1. 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;
  2. Has unstable angina classified as Braunwald III B or C and A I-II-III, or is having a peri infarction;
  3. Unprotected left main coronary disease with >=50% stenosis;
  4. Significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
  5. Have an ostial target lesion;
  6. Angiographic evidence of thrombus within target lesion;
  7. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated;
  8. 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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 April 16, 2014