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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00233818

Enrollment

Registered

2005-10-06

Start date

2000-02-29

Completion date

2005-06-30

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

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.

Interventions

DEVICESirolimus-coated Bx VELOCITY Stent

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 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

Netherlands

Outcome results

None listed

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