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

NCT ID: NCT00233818

Last Updated: 2007-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-02-29

Study Completion Date

2005-06-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type OTHER

Sirolimus-coated Bx VELOCITY Stent

Intervention Type DEVICE

Interventions

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Sirolimus-coated Bx VELOCITY Stent

Intervention Type DEVICE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cordis Corporation

INDUSTRY

Sponsor Role lead

Principal Investigators

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Patrick W Serruys, MD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Centrum Thoraxcentrum

Locations

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Erasmus Centrum Thoraxcentrum

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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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 follow-up. Eur Heart J. 2001 Nov;22(22):2125-30. doi: 10.1053/euhj.2001.2892.

Reference Type RESULT
PMID: 11686669 (View on PubMed)

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) clinical, angiographic, and intravascular ultrasound follow-up. Circulation. 2002 Sep 24;106(13):1610-3. doi: 10.1161/01.cir.0000034447.02535.d5.

Reference Type RESULT
PMID: 12270850 (View on PubMed)

Other Identifiers

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EC99-07

Identifier Type: -

Identifier Source: org_study_id