Trials / Withdrawn
WithdrawnNCT02784418
The SHINE-CTO Trial
SHam-controlled INtErvention to Improve QOL in CTOs: the SHINE CTO Trial
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Minneapolis Heart Institute Foundation · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2020-12-01
- Completion
- 2021-12-01
- First posted
- 2016-05-27
- Last updated
- 2021-06-07
Source: ClinicalTrials.gov record NCT02784418. Inclusion in this directory is not an endorsement.