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.

Multivessel Coronary Artery Disease Clinical Trial

— CABGRevolution  

Official title:

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03851276
• Other study ID #: ECRI-12
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 28, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: December 2019
• Source: ECRI bv
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient referred to CABG treatment (as assessed by 'conventional Heart Team');

2. Patients with at least 1 stenosis (visually determined de novo lesions with =50% DS) in all 3 major epicardial territories (LAD and/or side branch, CX and/or side branch, RCA and/or side branch) supplying viable myocardium with or without left main involvement;

3. Patients with hypoplastic right coronary artery (RCA) with absence of descending posterior and presence of a lesion in the LAD and circumflex (CX)territories may be included in the trial as a 3vessel disease equivalent. Ostial LAD plus ostial left circumflex artery (LCX) may be included in the trial as a Left Main equivalent

4. Distal vessel size should be at least 1.5 mm in diameter as visually assessed in diagnostic angiogram;

5. Patient with silent ischemia, chronic stable angina or stabilized acute coronary syndromes with normalized (stable or decreasing) cardiac biomarker values Note: For patients showing elevated Troponin (cTn) (e.g. non-STEMI patients) at baseline (within 24h pre-CABG) an additional blood sample must be collected prior to the CABG procedure to confirm that: • hs-cTn or Troponin I or T levels are stable, i.e. the value should be within 20% range of the value found in the first sample at baseline, or have dropped • CK-MB and CK levels are within normal range If hs-cTn or Troponin I or T levels are stable or have dropped, or the Creatine kinase-MB (CK-MB) and Creatine kinase (CK) levels are within normal ranges, and the ECG is normal, the patient may be included in the study.

6. All anatomical SYNTAX Scores are eligible;

7. Patient amenable to a MSCT coronary angiography (e.g. no claustrophobia, high heartrate not amenable to beta-blockers, poor renal function, etc., up to discretion of investigator);

8. Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site;

9. The patient agrees to the 1-month follow-up visit including a MSCT coronary angiography.

Exclusion Criteria:

1. Under the age of 18 years;

2. Unable to give Informed Consent;

3. Known pregnancy at time of enrollment. Female of childbearing potential i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause). Female who is breastfeeding at time of enrollment;

4. Prior percutaneous coronary intervention (PCI) or CABG; history of coronary stent implantation;

5. Evidence of evolving or ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice);

6. Known renal insufficiency (e.g. serum creatinine >2.5mg/dL, or creatinine clearance =30 mL/min), or subject on dialysis, or acute kidney failure (as per physician judgment);

7. Concomitant cardiac valve disease requiring surgical therapy (reconstruction or replacement) and/or aneurysmectomy;

8. Single or two-vessel disease (at time of the conventional Heart Team consensus);

9. Non-graftable distal bed in >1 vessel as assessed by the surgeon based on conventional angiography;

10. Atrial fibrillation or significant arrhythmias;

11. Known allergy to iodinated contrast;

12. A Body Mass Index (BMI) of 35 or greater;

13. Currently participating in another trial and not yet at its primary endpoint.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Multivessel Coronary Artery Disease
• Myocardial Ischemia

Intervention

Radiation:
• Multi-sliced computed tomography (MSCT)
Surgery planning done based solely on MSCT.

Locations

Country	Name	City	State
Belgium	University Hospital of Brussels	Brussels
Germany	University Hospital of Jena	Jena
Italy	Centro Cardiologico Monzino	Milan
Switzerland	University Hospital of Zurich	Zürich

Sponsors (3)

Lead Sponsor	Collaborator
ECRI bv	GE Healthcare, HeartFlow, Inc.

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients in the intention to treat (ITT) population for whom CABG planning and execution was based solely on MSCT.		2 weeks after enrollment
Primary	Number of graft/anastomoses for which graft/anastomosis stenosis (=50%DS - 99%DS) or occlusion (100%DS) occurred as percentage of the total number of intra graft/anastomoses.		1 month after surgery