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

Coronary Artery Disease Clinical Trial

Official title:

An Evaluation of Sirolimus-Coated Modified BX VELOCITY Balloon-Expandable Stents for the Treatment of Patients With de Novo Native Coronary Artery Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233818
• Other study ID #: EC99-07
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 4, 2005
• Last updated: October 11, 2007
• Start date: February 2000
• Est. completion date: June 2005

Study information

• Verified date: October 2007
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2005
• 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) 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Sirolimus-coated Bx VELOCITY Stent

Locations

Country	Name	City	State
Netherlands	Erasmus Centrum Thoraxcentrum	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Degertekin M, Serruys PW, Foley DP, Tanabe K, Regar E, Vos J, Smits PC, van der Giessen WJ, van den Brand M, de Feyter P, Popma JJ. Persistent inhibition of neointimal hyperplasia after sirolimus-eluting stent implantation: long-term (up to 2 years) clini — View Citation

Rensing BJ, Vos J, Smits PC, Foley DP, van den Brand MJ, van der Giessen WJ, de Feijter PJ, Serruys PW. Coronary restenosis elimination with a sirolimus eluting stent: first European human experience with 6-month angiographic and intravascular ultrasonic — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of in-stent percent diameter stenosis (%DS) measured by quantitative coronary angiography.		post procedure and 6 months
Secondary	Assessment of lesion morphology by intravascular ultrasound (IVUS).		post procedure and 6 months
Secondary	Target vessel failure (TVF).		6 months