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

NCT00233818 | Completed Phase 1 DMC

• 1 other identifier: EC99-07
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Assessment of in-stent percent diameter stenosis (%DS) measured by quantitative coronary angiography.

  post procedure and 6 months

Secondary Outcomes (2)

• Assessment of lesion morphology by intravascular ultrasound (IVUS).

  post procedure and 6 months

• Target vessel failure (TVF).

  6 months

Study Arms (1)

1

OTHER

Device: Sirolimus-coated Bx VELOCITY Stent

Interventions

Sirolimus-coated Bx VELOCITY Stent DEVICE

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS) or a positive ischemia study;
• Single de novo lesion requiring treatment in a major native coronary artery;
• Target lesion is \<=18mm in length (visual estimate);
• Target lesion is \>=3.0mm and \<=3.5mm in diameter (visual estimate);
• Target lesion stenosis is \>50% and \<100% (visual estimate);

You may not qualify if:

• 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;
• Unprotected left main coronary disease with \>=50% stenosis;
• Have an ostial target lesion;
• Angiographic evidence of thrombus within target lesion;
• Calcified lesions which cannot be successfully predilated;
• Ejection fraction \<=30%;
• Target lesion involves bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch);
• Totally occluded vessel;

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Erasmus Centrum Thoraxcentrum

Rotterdam, NL- 3015 GD, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 11686669 RESULT

• 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.

  PMID: 12270850 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Patrick W Serruys, MD

  Erasmus Centrum Thoraxcentrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 6, 2005
• Study Start: February 1, 2000
• Study Completion: June 1, 2005
• Last Updated: October 12, 2007

Record last verified: 2007-10

Locations

NL (1)