NCT00920283

Brief Summary

The COMPETE study is a prospective,randomized,two-arm multi-center clinical trial comparing two commercially available coronary stents: Chrono Carbostent Carbofilm™ Coated vs Driver/Micro-Driver Coronary Stent System. In this study, 204 subjects will be included (2:1 randomization Chrono:Driver/Micro Driver) in 6 Italian sites.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

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

First Submitted

Initial submission to the registry

June 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2009

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

3.4 years

First QC Date

June 12, 2009

Last Update Submit

May 2, 2018

Conditions

Coronary Atherosclerotic DiseaseCoronary Occlusive DiseasesCoronary Artery DiseasesMyocardial IschemiaCoronary Stenosis

Keywords

StentsBare Metal StentsPCICoronary Artery DiseaseCoronary Artery StenosisStent ThrombosisVascular DiseaseMyocardial Ischemia

Outcome Measures

Primary Outcomes (1)

  • in-stent late lumen loss (LLL)

    180 days

Secondary Outcomes (4)

  • Angiographic binary restenosis (diameter stenosis ≥50%)

    180 days

  • Clinical Composite Endpoints: - Cardiac death/ MI - Cardiac death / Target vessel MI / (Clinically indicated) TLR* - All death / MI / all repeat revascularization** *Device oriented composite endpoint **Patient oriented composite endpoint

    30 days, 180 days, 1 year

  • Stent Thrombosis

    acute, 30 days, 180 days, 1 year

  • Acute success (Device and Procedural success)

    acute

Study Arms (2)

Chrono Carbostent Carbofilm™ Coated Coronary Stent

EXPERIMENTAL
Device: Chrono Carbostent Carbofilm™ Coated Coronary Stent

Driver, Cobalt Alloy Coronary Stent

ACTIVE COMPARATOR
Device: Driver Cobalt Alloy Coronary Stent

Interventions

Chrono Carbostent Carbofilm™ Coated Coronary StentDEVICE
Chrono Carbostent Carbofilm™ Coated Coronary Stent
Driver Cobalt Alloy Coronary StentDEVICE
Driver, Cobalt Alloy Coronary Stent

Eligibility Criteria

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

You may qualify if:

  • Patients with clinical evidence of ischemic heart disease;
  • No clinical and ECG changes suggestive of ongoing acute infarction;
  • De novo lesion \> 50% and \<100% diameter stenosis (DS) in native coronary vessels TIMI flow of \>= 1.
  • Reference diameter \> 2.5 mm or \< 4.0 mm;
  • Patients with a maximum of two coronary lesions to be treated with a maximum of 2 study stents;

You may not qualify if:

  • Lesion length \> 30 mm;
  • Significant (\>50%) stenosis proximal or distal to the target lesions that might impede run off;
  • Lesions located in saphenous vein graft;
  • Lesions located in unprotected left main;
  • Presence of \> 40% stenosis in the left main;
  • Ostial lesion;
  • Lesion located in a bifurcation;
  • Target lesion with visible thrombus;
  • Chronic total occlusion;
  • Treatment of restenotic lesions;
  • Previous implantation of a stent (BMS/DES) in the target vessel.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Maria Cecilia Hospital

Cotignola, Ravenna, 48010, Italy

Location

Cardinal Massaia Hospital

Asti, 14100, Italy

Location

Azienda Ospedaliera Policlinico di Modena

Modena, Italy

Location

Ospedale Civile S.Agostino-Estense-Baggiovara

Modena, Italy

Location

Azienda Ospedaliera Universitaria

Roma, Italy

Location

Ospedale Civile Maggiore- Borgo Trento

Verona, Italy

Location

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial IschemiaCoronary StenosisVascular Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Flavio Airoldi, Dr

    Multimedica IRCCS, Sesto SG (MI) Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2009

First Posted

June 15, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

May 7, 2018

Record last verified: 2018-05

Locations

IT(6)