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

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.

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00233792

Enrollment

Registered

2005-10-06

Start date

1999-12-31

Completion date

2005-03-31

Last updated

2007-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief 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.

Detailed 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.

Interventions

DEVICEsirolimus coated Bx VELOCITY stent - fast release

DEVICEsirolimus coated Bx VELOCITY stent - slow release

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026