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The SHINE-CTO Trial

NCT02784418 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-06-07

No results posted yet for this study

Summary

Design: Single center, double-blind, sham-controlled trial that will randomize symptomatic patients with a coronary chronic total occlusion (CTO) to CTO percutaneous coronary intervention (PCI) or a sham procedure. All patients will receive optimal medical therapy.

Treatment:CTO PCI, as per standard clinical practice.

Control: Patients randomized to sham-procedure will undergo only bilateral arterial access, without angiography or PCI being performed.

Secondary Endpoints: (1) Greater improvement in SAQ-7 Summary scores during the entire duration of follow-up (6 months) using a repeated measures analysis (2) Greater improvement in individual components of patients' health status (3) Greater improvement in exercise capacity (4) Similar incidence of major adverse cardiac events (MACE), both peri-procedural and long-term

Conditions

  • Coronary Artery Disease
  • Chronic Total Occlusion of Coronary Artery
  • Percutaneous Transluminal Coronary Angioplasty

Interventions

PROCEDURE

Chronic Total Occlusion Percutaneous Coronary Intervention

Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI), as per standard clinical practice

PROCEDURE

Sham Procedure

Sham Procedure: Bilateral arterial access, without angiography or PCI being performed

Sponsors & Collaborators

  • Minneapolis Heart Institute Foundation

    lead OTHER

Principal Investigators

  • Emmanouil S Brilakis, MD, PhD · Minneapolis Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2020-12-31
Completion
2021-12-31

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Diseases

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 NCT02784418 on ClinicalTrials.gov