NCT00233792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 coronary-artery-disease

Timeline
Completed

Started Dec 1999

Longer than P75 for phase_1 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
Last Updated

October 12, 2007

Status Verified

October 1, 2007

First QC Date

October 4, 2005

Last Update Submit

October 11, 2007

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 (2)

1

OTHER

sirolimus coated Bx VELOCITY stent - fast release

Device: sirolimus coated Bx VELOCITY stent - fast release

2

OTHER

sirolimus coated Bx VELOCITY stent - slow release

Device: sirolimus coated Bx VELOCITY stent - slow release

Interventions

sirolimus coated Bx VELOCITY stent - fast releaseDEVICE
1
sirolimus coated Bx VELOCITY stent - slow releaseDEVICE
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 or restenotic 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Dante Pazzanese of Cardiology

São Paulo, 04012-909, Brazil

Location

Related Publications (4)

  • 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 arteries. Circulation. 2003 Jan 28;107(3):381-3. doi: 10.1161/01.cir.0000051720.59095.6d.

    PMID: 12551858RESULT

  • 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. 2005 May 10;111(18):2326-9. doi: 10.1161/01.CIR.0000164271.01172.1A. Epub 2005 Apr 25.

    PMID: 15851603RESULT

  • 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 analysis for plaque composition in event-free patients. J Am Coll Cardiol. 2005 Nov 1;46(9):1670-6. doi: 10.1016/j.jacc.2005.06.076. Epub 2005 Oct 10.

    PMID: 16256867RESULT

  • 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: a quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation. 2001 Jan 16;103(2):192-5. doi: 10.1161/01.cir.103.2.192.

    PMID: 11208675RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Eduardo J Sousa, MD

    Instituto Dante Pazzanese of Cardiology

    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

December 1, 1999

Study Completion

March 1, 2005

Last Updated

October 12, 2007

Record last verified: 2007-10

Locations

BR(1)