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

• Sponsor: Shanghai Zhongshan Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03522038
• Collaborator: (none)
• Enrollment: 300
• Anticipated Duration (Months): 23

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Occlusion; Angioplasty, Balloon, Coronary	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 Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Functional Assessment-guided Angioplasty in Patients With Coronary Chronic Total Occlusion (FAGA-CTO)
• Anticipated Study Start Date: Aug 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2019
• Anticipated Study Completion Date: Jun 30, 2020

Outcome Measures

Primary Outcome Measures

1. Change from Baseline FFR at 6 months after CTO PCI [At baseline and 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.

2. Change from Baseline FFR at 6 months after CTO PCI [At baseline and 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.

3. Change from Baseline Myocardial perfusion at 6 months after CTO PCI [At baseline and 6 months after CTO PCI]

   The myocardial perfusion before and after CTO PCI was evaluated by dynamic SPECT.

4. Change from Baseline Myocardial Viability at 6 months after CTO PCI [At baseline and 6 months after CTO PCI]

   The myocardial viability before and after CTO PCI was evaluated by PET-MRI.

Secondary Outcome Measures

1. MACE [6 months after CTO PCI]

   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.

2. In-stent restenosis [6 months after CTO PCI]

   In-stent restenosis was defined as >50% diameter stenosis by quantitative coronary angiography within a previously stented CTO vessel segment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai Zhongshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Zhongshan Hospital
• ClinicalTrials.gov Identifier: NCT03522038
• Other Study ID Numbers: ZS-CV-201801
• First Posted: May 11, 2018
• Last Update Posted: May 11, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shanghai Zhongshan Hospital: coronary chronic total occlusion; functional evaluation
• Additional relevant MeSH terms: Coronary Occlusion

Study Results

No Results Posted as of May 11, 2018