NCT00232739

Brief Summary

The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion restenosis in patients with de novo native coronary artery lesions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3 coronary-artery-disease

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_3 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

September 1, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
6 months until next milestone

Results Posted

Study results publicly available

February 8, 2010

Completed
Last Updated

March 16, 2010

Status Verified

March 1, 2010

Enrollment Period

1.2 years

First QC Date

October 3, 2005

Results QC Date

October 19, 2009

Last Update Submit

March 11, 2010

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure

    In-lesion restenosis was defined as over 50 percent diameter stenosis either within the stented segment or within 5 mm proximal or distal to the stent edges at a qualifying follow-up angiogram.

    From post-procedure to 6 months

Secondary Outcomes (13)

  • Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up

    From post-procedure to 4 years

  • Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure.

    From post-procedure to 6 months

  • Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure.

    From post-procedure to 6 months

  • Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure.

    From post-procedure to 6 months and 9 months

  • Cumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure.

    From post-procedure to 6 months and 9 months follow-up

  • +8 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL
Device: CYPHER Sirolimus-eluting Coronary Stent

Interventions

CYPHER Sirolimus-eluting Coronary StentDEVICE

2.25 Cypher Sirolimus-eluting Coronary Stent

1

Eligibility Criteria

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

You may qualify if:

  • Male or non-pregnant female patients 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) OR patients with documented silent ischemia;
  • Target lesion is 20mm in length (visual estimate);
  • Target lesion stenosis is \>50% and \<100% (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 remains above normal at the time of treatment;
  • Has unstable angina classified as Braunwald III B or C, or is having a peri infarction;
  • Documented Left ventricular ejection fraction 25%;
  • Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lenox Hill Hospital

New York, New York, 10021, United States

Location

Related Publications (1)

  • Moses JW, Nikolsky E, Mehran R, Cambier PA, Bachinsky WB, Leya F, Kuntz RE, Popma JJ, Schleckser P, Wang H, Cohen SA, Leon MB; SIRIUS 2.25 Investigators. Safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in the treatment of patients with de novo native coronary artery lesions: the SIRIUS 2.25 trial. Am J Cardiol. 2006 Dec 1;98(11):1455-60. doi: 10.1016/j.amjcard.2006.06.047. Epub 2006 Oct 13.

    PMID: 17126649BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Results Point of Contact

Title
Sidney Cohen, MD PhD, Vice President
Organization
Cordis
scohen7@its.jnj.com
650 614-2726

Study Officials

  • Sriram Iyer, MD

    Lenox Hill Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 5, 2005

Study Start

September 1, 2003

Primary Completion

November 1, 2004

Study Completion

August 1, 2009

Last Updated

March 16, 2010

Results First Posted

February 8, 2010

Record last verified: 2010-03

Locations

US(1)