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

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235144
• Other study ID #: EC00-07
• Status: Completed
• Phase: Phase 3
• First received: October 4, 2005
• Last updated: May 8, 2009
• Start date: March 2001
• Est. completion date: September 2008

Study information

• Verified date: May 2009
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: September 2008
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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%;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• sirolimus-coated Bx Velocity stent
drug-eluting stent
• uncoated Bx Velocity stent
bare-metal stent

Locations

Country	Name	City	State
Germany	Herzkatheterlabor und Praxisklinik	Hamburg
Germany	Med. Klinik und Poliklinik	Münster

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. Epub 2007 Aug 29. — View Citation

Schampaert E, Moses JW, Schofer J, Schlüter 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, — View Citation

Schlüter 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 trial — View Citation

Schofer J, Schlüter 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 controlle — View Citation

Outcome

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