The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions.

NCT00232791 | Completed Phase 2 DMC

• 1 other identifier: EC03-04
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the CYPHER ™ Sirolimus-eluting Coronary Stent.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Angiographic in-stent late loss

  6 months

Secondary Outcomes (7)

• In-stent mean percent diameter stenosis

  anytime post-procedure

• In-target vessel segment MLD

  6 months

• In-stent MLD

  6 months

• Target Lesion Revascularization (TLR)

  6 months

• Target Vessel Revascularization (TVR)

  6 months

Study Arms (2)

1

EXPERIMENTAL

CYPHER SELECT™ Sirolimus-eluting Coronary Stent

Device: Cypher Select

2

ACTIVE COMPARATOR

CYPHER™ Sirolimus-eluting Coronary Stent

Device: Cypher

Interventions

Cypher Select DEVICE

CYPHER SELECT™ Sirolimus-eluting Coronary Stent

Also known as: PTCA

1

Cypher DEVICE

CYPHER™ Sirolimus-eluting Coronary Stent

Also known as: PTCA

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-III) OR patients with documented silent ischemia;
• Single treatment of de novo lesion in a coronary artery which can be appropriately covered by a study stent up to 23mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions are successfully treated before the target lesion;
• Target lesion is more than 2.5 and less than 3.5mm in diameter (visual estimate);
• Target lesion is located in a native coronary artery with a maximum lesion length that can be adequately covered by a single 23 mm stent;
• Target lesion stenosis is \> 50% and \< 100% (visual estimate).

You may not qualify if:

• A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
• Unprotected left main coronary disease with more than 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;
• Calcified lesions which cannot be successfully predilated;
• Ejection fraction less than 30%;
• Totally occluded vessel (TIMI 0 level);
• Direct Stenting;

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Cardiothoracic Center Liverpool

Liverpool, L14 3PE, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• R. H. Stables, MD

  Cardiothoracic Centre Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 5, 2005
• Study Start: January 1, 2004
• Primary Completion: August 1, 2004
• Study Completion: March 1, 2005
• Last Updated: August 6, 2008

Record last verified: 2008-08

Locations

GB (1)