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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014