FIM-BR - First-in-Man Study (Brazil Part) With Sirolimus-Coated BX VELOCITY Stent

Coronary Artery Disease Clinical Trial

Official title:

An Evaluation of the Sirolimus Coated Modified BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo or Restenotic Native Coronary Artery Lesions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233792
• Other study ID #: P99-6301
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 4, 2005
• Last updated: October 11, 2007
• Start date: December 1999
• Est. completion date: March 2005

Study information

• Verified date: October 2007
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

This is a single center, non-randomized study. Patients will be treated with the sirolimus coated Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will have a repeat angiography at four months and will be followed for twelve months post-procedure.

Description:

This is a single center, non-randomized study of the Bx VELOCITY Balloon-Expandable Stent coated with sirolimus (140µg/cm2) and formulated for fast or slow release. The sirolimus coated stent is mounted on the Raptor OTW SDS. Approximately 30 patients with de novo or restenotic native coronary artery lesions <=18mm in length and >=3.0 to >=3.5 mm in diameter by visual estimate who meet all eligibility criteria will be treated with the sirolimus coated Bx VELOCITY stent(s). Patients will be followed for five years post-procedure and will have a repeat angiography at 4 months, 12 months, 24 months, and 48 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 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 or restenotic 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 - fast release

• sirolimus coated Bx VELOCITY stent - slow release

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese of Cardiology	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Aoki J, Abizaid AC, Serruys PW, Ong AT, Boersma E, Sousa JE, Bruining N. Evaluation of four-year coronary artery response after sirolimus-eluting stent implantation using serial quantitative intravascular ultrasound and computer-assisted grayscale value a — View Citation

Sousa JE, Costa MA, Abizaid A, Abizaid AS, Feres F, Pinto IM, Seixas AC, Staico R, Mattos LA, Sousa AG, Falotico R, Jaeger J, Popma JJ, Serruys PW. Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: — View Citation

Sousa JE, Costa MA, Abizaid A, Feres F, Seixas AC, Tanajura LF, Mattos LA, Falotico R, Jaeger J, Popma JJ, Serruys PW, Sousa AG. Four-year angiographic and intravascular ultrasound follow-up of patients treated with sirolimus-eluting stents. Circulation. — View Citation

Sousa JE, Costa MA, Sousa AG, Abizaid AC, Seixas AC, Abizaid AS, Feres F, Mattos LA, Falotico R, Jaeger J, Popma JJ, Serruys PW. Two-year angiographic and intravascular ultrasound follow-up after implantation of sirolimus-eluting stents in human coronary — 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