Safety and Feasibility Evaluation of Planning and Execution of Surgical Revascularization Solely Based on Coronary CTA and FFRCT in Patients With Complex Coronary Artery Disease (FASTTRACK CABG)

Coronary Artery Disease Clinical Trial

Official title:
A Multicenter, Pilot Study to Evaluate Safety and Feasibility Evaluation of Planning and Execution of Surgical Revascularization Solely Based on Coronary CTA and FFRCT in Patients With Complex Coronary Artery Disease (FASTTRACK CABG)

Status Recruiting

Clinical Trial Summary

To assess the feasibility of coronary computed tomography angiography (CTA) and fractional flow reserve derived from CTA (FFRCT) to replace invasive coronary angiography (ICA) as a surgical guidance method for planning and execution of coronary artery bypass graft (CABG) in patients with 3-vessel disease with or without left main disease. The FASTTRACK CABG study is an investigator-initiated single-arm, multicentre, prospective, proof-of-concept, and first-in-man study with feasibility and safety analysis. Surgical revascularization strategy and treatment planning will be solely based on coronary CTA and FFRCT without knowledge of the anatomy defined otherwise by ICA that will be viewed and analyzed only by the conventional heart team. Clinical follow-up visit including coronary CTA will be performed 30 days after CABG in order to assess graft patency and adequacy of the revascularization with respect to the surgical planning based on non-invasive imaging with functional assessment and compared to ICA. Primary feasibility endpoint is CABG planning and execution solely based on coronary CTA in 114 patients. Primary safety endpoint based on 30-day coronary CTA is graft assessment either at the ostium, in the shaft or at the anastomoses of each individual graft either single or sequential. The FASTTRACK CABG study is the first study to assess safety and feasibility of planning and execution of surgical revascularization in patients with complex coronary artery disease, solely based on coronary CTA combined with FFRCT.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04142021
Study type	Observational
Source	National University of Ireland, Galway, Ireland
Contact	Hideyuki Kawashima, MD
Phone	+353870696945
Email	h.kawashima429@gmail.com
Status	Recruiting
Phase
Start date	September 1, 2020
Completion date	December 31, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06030596` - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed	`NCT04080700` - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting	`NCT03810599` - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study	N/A
Recruiting	`NCT06002932` - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.	N/A
Not yet recruiting	`NCT06032572` - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)	N/A
Recruiting	`NCT04242134` - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions	N/A
Recruiting	`NCT05308719` - Nasal Oxygen Therapy After Cardiac Surgery	N/A
Completed	`NCT04556994` - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.	N/A
Recruiting	`NCT05846893` - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease	N/A
Recruiting	`NCT06027788` - CTSN Embolic Protection Trial	N/A
Recruiting	`NCT05023629` - STunning After Balloon Occlusion	N/A
Completed	`NCT04941560` - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed	`NCT04006288` - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease	Phase 4
Completed	`NCT01860274` - Meshed Vein Graft Patency Trial - VEST	N/A
Recruiting	`NCT06174090` - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients	N/A
Completed	`NCT03968809` - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated	`NCT03959072` - Cardiac Cath Lab Staff Radiation Exposure
Recruiting	`NCT04566497` - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.	N/A
Recruiting	`NCT05065073` - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography	Phase 4
Completed	`NCT05096442` - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.