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Randomized Comparison of Optimal Medical Therapy and Percutaneous Recanalization for Chronic Total Occlusion (COMET-CTO)

NCT02964975 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-04-24

No results posted yet for this study

Summary

Several meta analysis comparing successful Percutaneous Coronary Intervention of Chronic Total Occlusion (PCI-CTO) with unsuccessful PCI-CTO showed that there is significant reduction in short-term and long-term mortality. To our knowledge till today no prospective randomized trial compared percutaneous revascularization of CTO with optimal medical therapy. For this reason quality of live improvement is one of the most important indications for revascularization in elective patients with CTO. In contemporary literature Seattle Angina Questionnaire (SAQ) is a psychometrically solid disease-specific instrument designed to assess the functional status of patients with angina. It comprises 19 questions that quantify five clinically relevant domains: physical limitation, angina stability, angina frequency, treatment satisfaction and disease perception/quality of life.

In this open prospective study patients with CTO of coronary artery will be randomized in two groups: first - patients with percutaneous coronary intervention of chronic total occlusion with optimal medical therapy and second group - patients with only optimal medical therapy (control group). Primary endpoint will be quality of life and secondary endpoints will be mayor adverse cardiovascular events (MACE). All patients will complete Seattle Angina Questionnaire before randomization and after 6 months of follow-up.

Conditions

  • Chronic Total Occlusions of Coronary Arteries

Interventions

PROCEDURE

Percutaneous coronary intervention

Recanalisation of chronic total occlusion of coronary artery

DRUG

Optimal medical therapy

Medical threatment according to guidelines

Sponsors & Collaborators

  • Clinical Centre of Serbia

    lead OTHER

Principal Investigators

  • Sinisa Stojkovic, PhD · Clinical Centre of Serbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-11-30
Completion
2017-12-31

Countries

  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02964975 on ClinicalTrials.gov