NCT01078051

Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO)

Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 840 (actual)
• Sponsor: Seung-Jung Park · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and effectiveness of drug-eluting stent implantation compared to optimal medical treatment in patients with chronic total occlusion.

Detailed description

Prospective, two arms, randomized multi-center trial in Asian-pacific region. Following angiography, patients with chronic total occlusion (more than 3 months) have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) drug-eluting stent vs. b) optimal medical treatment. All patients will be followed for at least 3 year. The subjects with chronic total occlusion but failed to random for any reason, they will be enrolled in registry group. The random design was closed at the date of 22 July 2019 however already randomized subjects and subjects from registry design continue 10 years follow-up on IRIS-CTO registry.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Cypher, xience, Endeavor, Taxus	all species of drug-eluting stent implantation
DRUG	optimal medical therapy	optimal medical therapy

Timeline

• Start date: 2010-03-22
• Primary completion: 2019-07-22
• Completion: 2019-07-22
• First posted: 2010-03-02
• Last updated: 2019-08-02

Locations

26 sites across 5 countries: India, Indonesia, South Korea, Taiwan, Thailand