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.

NCT03851276 | Withdrawn Phase 4 DMC

• 1 other identifier: ECRI-12
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 4

Brief 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.

Conditions

Multivessel Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Patients with 3-vessels diseased referred to CABG surgery

OTHER

Patients with 3-vessel disease (with or without left main involvement) for which the regular and conventional Heart Team has made already the decision to refer the patient for CABG treatment.

Radiation: Multi-sliced computed tomography (MSCT)

Interventions

Multi-sliced computed tomography (MSCT) RADIATION

Surgery planning done based solely on MSCT.

Patients with 3-vessels diseased referred to CABG surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient referred to CABG treatment (as assessed by 'conventional Heart Team');
• 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;
• 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
• Distal vessel size should be at least 1.5 mm in diameter as visually assessed in diagnostic angiogram;
• 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.
• All anatomical SYNTAX Scores are eligible;
• 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);
• 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;
• The patient agrees to the 1-month follow-up visit including a MSCT coronary angiography.

You may not qualify if:

• Under the age of 18 years;
• Unable to give Informed Consent;
• 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;
• Prior percutaneous coronary intervention (PCI) or CABG; history of coronary stent implantation;
• Evidence of evolving or ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice);
• 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);
• Concomitant cardiac valve disease requiring surgical therapy (reconstruction or replacement) and/or aneurysmectomy;
• Single or two-vessel disease (at time of the conventional Heart Team consensus);
• Non-graftable distal bed in \>1 vessel as assessed by the surgeon based on conventional angiography;
• Atrial fibrillation or significant arrhythmias;
• Known allergy to iodinated contrast;
• A Body Mass Index (BMI) of 35 or greater;
• Currently participating in another trial and not yet at its primary endpoint.

Sponsors & Collaborators

• ECRI bv: lead
• GE Healthcare: collaborator
• HeartFlow, Inc.: collaborator

Study Sites (4)

University Hospital of Brussels

Brussels, Belgium

Location

University Hospital of Jena

Jena, Germany

Location

Centro Cardiologico Monzino

Milan, Italy

Location

University Hospital of Zurich

Zurich, Switzerland

Location

Study Officials

• Patrick W Serruys, Prof. dr.

  NHLI Imperial College, London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 22, 2019
• Study Start: June 28, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: December 6, 2019

Record last verified: 2019-12

Locations

IT (1); CH (1); DE (1); BE (1)