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Procedure

Percutaneous Coronary Intervention for Cardiovascular Disease

Phase 3
Waitlist Available
Research Sponsored by Valentin Fuster
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at year 5
Awards & highlights

Study Summary

The purpose of this study is to compare 5-year mortality rates in diabetic individuals with multivessel coronary artery disease (CAD) who undergo either coronary artery bypass grafting (CABG) surgery or percutaneous coronary stenting.

Eligible Conditions
  • Cardiovascular Disease
  • Heart Disease
  • Coronary Heart Disease
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at year 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at year 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke
Secondary outcome measures
All-cause Mortality
Major MACCE Rates, Including the First of One of the Following: Death, Myocardial Infarction, Stroke, or Repeat Revascularization
Rates of Individual MACCE Endpoints

Side effects data

From 2020 Phase 4 trial • 777 Patients • NCT01985360
19%
Death from any cause or Initiation of dialysis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Invasive Strategy
Conservative Strategy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Percutaneous Coronary InterventionExperimental Treatment1 Intervention
Percutaneous Coronary Intervention
Group II: Coronary Artery Bypass GraftActive Control1 Intervention
Coronary Artery Bypass Graft
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Percutaneous Coronary Intervention
2017
Completed Phase 4
~446090

Find a Location

Who is running the clinical trial?

Valentin FusterLead Sponsor
2 Previous Clinical Trials
5,739 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,835 Previous Clinical Trials
47,308,742 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes (FREEDOM)
Valentin Fuster 2004. "Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes (FREEDOM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00086450.
All > Coronary Artery Disease > Diabetes
~90 spots leftby Apr 2025
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