CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 1,900 enrolled
Drug / intervention
Coronary Artery Bypass Graft +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00086450
NCT00086450Phase 3Unknown

Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease (FREEDOM)

Valentin Fuster·interventional·Posted Jul 5, 2004·Updated Feb 6, 2017

In Brief

A Phase 3 clinical trial evaluating Coronary Artery Bypass Graft and Percutaneous Coronary Intervention for Cardiovascular Diseases and 3 related conditions. Targeting 1,900 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3UnknownOverdue
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 5, 2004
Enrollment StartApr 1, 2004
Primary CompletionJul 1, 2012
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 22.0 years ago

Interventions

Coronary Artery Bypass Graftprocedure

For CABG, participants will receive general anesthesia and will have a breathing tube placed in their throat and they will be unconscious during the operation. An incision is made through the chest bone and muscle, which allows the surgeon access to the heart and diseased vessels. The surgeon will use one or more healthy vessels (either from an artery in the shoulder or a vein in the leg) and will bypass the diseased vessel with the healthy vessel(s). This bypass will provide needed blood supply to the heart.

Percutaneous Coronary Interventiondevice

For PCI, the participant will have two or more drug-eluting stents permanently implanted in their clogged arteries. Drug-eluting stents are coated with a drug that may prevent the disease in the vessel from coming back. The brand names of the stents used in this study are TAXUS and CYPHER. The participant will receive a local anesthetic. A small puncture will be made and a balloon-tipped catheter is introduced through the small puncture in the leg/arm and advanced through the artery to the diseased heart vessel. The balloon is then inflated to enlarge the opening in the vessel. After enlarging the vessel, the drug-eluting stent will be placed using a similar balloon catheter. This balloon will be inflated, expanding the stent and placing it in the diseased vessel. Once the stent is fully expanded, the balloon is deflated and removed, leaving the stent in place in the artery.