Clinical trial NCT00232791: The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions.
Official title: A Randomized Study With the CYPHER SELECT™ Sirolimus-Eluting Balloon-Expandable Coronary Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a multicenter (up to 10 sites), open, prospective, 2-arm, unbalanced, randomized study designed to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent as compared to the CYPHER™ Sirolimus-eluting Coronary Stent. A total of 100 patients will be entered in the study and will be randomized on a 2:1 basis to the CYPHER SELECT™ stent or the CYPHER™ stent. 100 patients with de novo native coronary artery lesions \<23 mm in length and more than 2.5 to less than 3.5 mm in diameter by visual estimate who meet all eligibility criteria will be either randomized.

Eligibility 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-III) OR patients with documented silent ischemia;
2. 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;
3. Target lesion is more than 2.5 and less than 3.5mm in diameter (visual estimate);
4. 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;
5. Target lesion stenosis is \> 50% and \< 100% (visual estimate).

Exclusion Criteria:

1. 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;
2. Unprotected left main coronary disease with more than 50% stenosis;
3. Significant (\>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
4. Have an ostial target lesion;
5. Angiographic evidence of thrombus within target lesion;
6. Calcified lesions which cannot be successfully predilated;
7. Ejection fraction less than 30%;
8. Totally occluded vessel (TIMI 0 level);
9. Direct Stenting;

Primary outcomes:
measure: Angiographic in-stent late loss
timeFrame: 6 months
Secondary outcomes:
measure: In-stent mean percent diameter stenosis
timeFrame: anytime post-procedure
measure: In-target vessel segment MLD
timeFrame: 6 months
measure: In-stent MLD
timeFrame: 6 months
measure: Target Lesion Revascularization (TLR)
timeFrame: 6 months
measure: Target Vessel Revascularization (TVR)
timeFrame: 6 months
measure: Major Adverse Cardiac Events (MACE)
timeFrame: 30 days, 6 and 12 months
measure: In-stent volume of restenosis determined by IVUS
timeFrame: 6 months
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Cardiothoracic Center Liverpool
Study officials:
affiliation: Cardiothoracic Centre Liverpool
name: R. H. Stables, MD
role: PRINCIPAL_INVESTIGATOR
References: