FIM-NL - First-in-Man Study (Netherlands Part) With Sirolimus Coated Modified BX Velocity Stent

Phase 1

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Sirolimus-coated Bx VELOCITY Stent

• Registration Number: NCT00233818
• Lead Sponsor: Cordis Corporation

Brief Summary

The objective of this study is to assess the performance and safety of a formulation of the antiproliferative agent, sirolimus coated on modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor Over The Wire (OTW) Stent Delivery System (SDS) in patients with de novo coronary artery lesions.

Detailed Description

This is a single center, non-randomized study. Patients who meet the eligibility criteria will be treated with the sirolimus coated modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will be followed for five years post-procedure, with all patients having a repeat angiography at 6 months, 18 months, and 48 months.

Study Timeline

• Study Start: 2000-02
• Study Completion: 2005-06
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-05
• Study First Posted: 2005-10-06
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-11
• Last Update Posted: 2007-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS) or a positive ischemia study;
2. Single de novo lesion requiring treatment in a major native coronary artery;
3. Target lesion is <=18mm in length (visual estimate);
4. Target lesion is >=3.0mm and <=3.5mm in diameter (visual estimate);
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 >=50% stenosis;
3. Have an ostial target lesion;
4. Angiographic evidence of thrombus within target lesion;
5. Calcified lesions which cannot be successfully predilated;
6. Ejection fraction <=30%;
7. Target lesion involves bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch);
8. Totally occluded vessel;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Sirolimus-coated Bx VELOCITY Stent	-

Primary Outcome Measures

Name	Time	Method
Assessment of in-stent percent diameter stenosis (%DS) measured by quantitative coronary angiography.	post procedure and 6 months

Secondary Outcome Measures

Name	Time	Method
Target vessel failure (TVF).	6 months
Assessment of lesion morphology by intravascular ultrasound (IVUS).	post procedure and 6 months

Trial Locations

Locations (1)

Erasmus Centrum Thoraxcentrum; 🇳🇱 Rotterdam, Netherlands