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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235144
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : May 11, 2009
Information provided by:
Cordis Corporation

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 353 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2001
Actual Primary Completion Date : October 2002
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. In-stent minimum lumen diameter (MLD). [ Time Frame: 8 months. ]

Secondary Outcome Measures :
  1. 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. ]
  2. Angiographic binary restenosis (>=50% diameter stenosis). [ Time Frame: 8 months. ]
  3. In-lesion MLD. [ Time Frame: 8 months. ]
  4. Target lesion revascularization. [ Time Frame: 9 months. ]
  5. Target vessel revascularization. [ Time Frame: 9 months. ]
  6. Target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization. [ Time Frame: 9 months. ]
  7. Device success (final residual diameter stenosis of < 50%). [ Time Frame: any time post-procedure. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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%;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00235144

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Herzkatheterlabor und Praxisklinik
Hamburg, Germany
Med. Klinik und Poliklinik
Münster, Germany
Sponsors and Collaborators
Cordis Corporation
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Principal Investigator: Joachim Schofer, MD Herzkatheterlabor und Praxisklinik, Hamburg
Principal Investigator: Günter Breithardt, MD Med. Klinik und Poliklinik, Münster

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Hans-Peter Stoll, Cordis Identifier: NCT00235144    
Other Study ID Numbers: EC00-07
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: May 11, 2009
Last Verified: May 2009
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs