Trials / Withdrawn
WithdrawnNCT03851276
A Multicentre, Pilot Study to Evaluate the Safety and the Feasibility of Planning and Execution of Surgical Revascularization in Patients With Complex Coronary Artery Disease, Based Solely on MSCT Imaging Utilizing GE Healthcare Revolution CT and HeartFlow FFRCT.
A Multicentre, Single Arm Pilot Study to Evaluate the Safety and the Feasibility of Planning and Execution of Surgical Revascularization in Patients With Complex Coronary Artery Disease, Based Solely on Non-invasive MSCT Angiography Imaging Utilizing High-definition GE Healthcare RevolutionTM CT and HeartFlow FFRCT.
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- ECRI bv · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The CABG-REVOLUTION study is an investigator-initiated single-arm, multicentre, prospective study for patients with 3-vessel disease (with or without left-main involvement) referred to CABG treatment. Surgical revascularization strategy and treatment planning will be solely based on MSCT (with FFRCT) without knowledge of the anatomy defined by conventional cine-angiography.
Detailed description
The CABG-REVOLUTION study is an investigator-initiated single-arm, multicentre, prospective study for patients with 3-vessel disease (with or without left-main involvement) referred to CABG treatment. Surgical revascularization strategy and treatment planning will be solely based on MSCT (with FFRCT) without knowledge of the anatomy defined by conventional cine-angiography. One clinical follow-up visit including MSCT acquisition will be performed at 30 days after bypass surgery in order to assess graft patency and adequacy of the revascularization with respect to the surgical planning based on non-invasive imaging.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Multi-sliced computed tomography (MSCT) | Surgery planning done based solely on MSCT. |
Timeline
- Start date
- 2019-06-28
- Primary completion
- 2020-03-30
- Completion
- 2020-03-30
- First posted
- 2019-02-22
- Last updated
- 2019-12-06
Locations
4 sites across 4 countries: Belgium, Germany, Italy, Switzerland
Source: ClinicalTrials.gov record NCT03851276. Inclusion in this directory is not an endorsement.