Functional Assessment-guided Angioplasty in Patients With Coronary Chronic Total Occlusion (FAGA-CTO)

Functional Assessment-guided Angioplasty in Patients With Coronary Chronic Total Occlusion (FAGA-CTO)

The aim of this study is to investigate the role of functional evaluation for predicting clinical outcome in patients with coronary chronic total occlusion (CTO) undergoing percutaneous coronary intervention (PCI), and to evaluate the clinical evidence for the using of fractional flow reserve (FFR), coronary flow reserve (CFR), index of myocardial resistance (IMR) and dynamic single photon emission computed tomography (D-SPECT) in these patients.

Study Overview

• Status: Unknown
• Conditions: Coronary Occlusion; Angioplasty, Balloon, Coronary
• Intervention / Treatment: Procedure: percutaneous coronary intervention

Detailed Description

PCI for CTO has dramatically changed in recent years. Although, with the improvement of devices and refinement of operator techniques, PCI of CTO can currently be performed with high success and low complication rates at experienced centers, the clinical benefit of recanalization of CTO is still a matter of debate. Accumulating evidence suggests that the improvement of left ventricular functional and prognosis is closely related with the area of viable myocardium, which has the potential for contractile recovery after revascularization. For the majority of interventional cardiologists, coronary angiography is the only invasive test deemed necessary for clinical decision-making, despite its weak ability to predict the functional impact of vascular occlusion on the subtended myocardium. To overcome this limitation, adjunctive diagnostic tools for functional evaluation, such as FFR, CFR, IMR and D-SPECT, have been introduced. In non-CTO patients, physiology-guided revascularization strategy has been definitely proven to be better than angiography-guided strategy in pivotal landmark studies. However, the clinical value of these functional parameters for the PCI of CTO is still unknown.

The aim of this study was to determine whether functional evaluation is a better predictor of clinical outcome in patients with CTO undergoing PCI.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Junbo Ge, MD; Phone Number: 2728 86-21-64041990; Email: jbge@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Coronary CTOs were defined as coronary lesions with Thrombolysis in Myocardial Infarction (TIMI) grade 0 flow of at least 3-month duration. Estimation of the occlusion duration was based on first onset of anginal symptoms, prior history of MI in the target vessel territory, or comparison with a prior angiogram.

Description

Inclusion Criteria:

• Age ≥ 18 and ≤80
• Patients diagnosed with CTO by coronary angiography
• Patient planned to receive PCI
• Diameter of CTO vessel > 2.25 mm

Exclusion Criteria:

• Age >80 or <18
• Myocardial infarction with 1 months
• Inability to give informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline FFR at 6 months after CTO PCI	FFR measurement in donor vessels at were performed simultaneously using pressure wires (Abbot) before attempting the CTO vessel. FFR measurement in the CTO vessels were performed after the wire arrived at the distal true lumen through antegrade or retrograde route. The FFR in donor and CTO vessels were measured again after successful stenting of CTO vessels.	At baseline and 6 months after CTO PCI
Change from Baseline FFR at 6 months after CTO PCI	CFR measurement in donor vessels at were performed simultaneously using pressure wires (Abbot) before attempting the CTO vessel. CFR measurement in the CTO vessels were performed after the wire arrived at the distal true lumen through antegrade or retrograde route. The CFR in donor and CTO vessels were measured again after successful stenting of CTO vessels.	At baseline and 6 months after CTO PCI
Change from Baseline Myocardial perfusion at 6 months after CTO PCI	The myocardial perfusion before and after CTO PCI was evaluated by dynamic SPECT.	At baseline and 6 months after CTO PCI
Change from Baseline Myocardial Viability at 6 months after CTO PCI	The myocardial viability before and after CTO PCI was evaluated by PET-MRI.	At baseline and 6 months after CTO PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	A major adverse cardiac event (MACE) was defined as the occurrence of cardiac death, nonfatal MI, and target lesion revascularization during the follow-up period.	6 months after CTO PCI
In-stent restenosis	In-stent restenosis was defined as >50% diameter stenosis by quantitative coronary angiography within a previously stented CTO vessel segment.	6 months after CTO PCI

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 29, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: April 29, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: functional evaluation; coronary chronic total occlusion
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Occlusion
• Other Study ID Numbers: ZS-CV-201801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No