NCT00233779

Brief Summary

The objective of this study is to assess the performance and safety of a sirolimus-eluting, heparin-coated, cobalt chromium balloon-expandable stent (Small Vessel Stent) in patients with de novo native coronary artery lesions in small vessels as compared to historical data from small vessel patients in the RAVEL trial receiving the Sirolimus-eluting Bx VELOCITY™ stent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_2 coronary-artery-disease

Timeline
Completed

Started Oct 2003

Shorter than P25 for phase_2 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

October 1, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 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

June 27, 2007

Status Verified

June 1, 2007

First QC Date

October 4, 2005

Last Update Submit

June 26, 2007

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is in-stent late loss as measured by quantitative coronary angiography (QCA) at 6 months post-procedure.

    6 months post-procedure

Secondary Outcomes (7)

  • In-lesion late loss as measured by QCA at 6 months post-procedure.

    6 months post-procedure

  • In-stent and in-lesion minimum lumen diameter (MLD) and percent diameter stenosis (%DS) by QCA post-procedure and at 6 months.

    Post-procedure and at 6 months

  • Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.

  • Target Lesion Revascularization (TLR) at six and 12 months.

    6 and 12 months

  • Target Vessel Revascularization (TVR) at six and 12 months.

    6 and 12 months

  • +2 more secondary outcomes

Interventions

SIROLIMUS-ELUTING, HEPARIN-COATED CoCr BALLOON-EXPANDABLE STENTDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must be minimum 18 years of age;
  • Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia;
  • Treatment of one lesion in a native coronary artery. The treated lesion will be the one with the highest % diameter stenosis by visual estimate. Additional study stents may be used for procedural complications such as dissections. Multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. If other non-target vessels are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;
  • \. The target lesion is \>/=2.0 mm and \</=2.5mm in diameter (visual estimate);
  • \. The target lesion can be covered with a single 18mm stent;
  • \. Target lesion stenosis is \>50% and \<100% (TIMI I) (visual estimate);

You may not qualify if:

  • Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK\>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;
  • Target lesion is due to in-stent restenosis;
  • Ejection fraction 30%;
  • Totally occluded vessel (TIMI 0 level);
  • Impaired renal function (creatinine \> 3.0 mg/dL);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • J. E. Sousa, MD

    Instituto Dante Pazzanese de Cardiologia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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

October 1, 2003

Study Completion

December 1, 2004

Last Updated

June 27, 2007

Record last verified: 2007-06

Locations

BR(1)