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

Coronary Occlusion Clinical Trial

— FAGA-CTO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03522038
• Other study ID #: ZS-CV-201801
• Status: Not yet recruiting
• Start date: August 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2018
• Source: Shanghai Zhongshan Hospital
• Contact: Junbo Ge, MD
• Phone: 86-21-64041990
• Email: jbge[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Angioplasty, Balloon, Coronary
• Coronary Occlusion

Intervention

Procedure:
• percutaneous coronary intervention
PCI was performed using standard techniques. Antiplatelet and antithrombotic agents were prescribed according to current PCI guidelines. A procedure was considered successful when achieving TIMI flow grade 3 with <30% angiographic residual stenosis in the CTO vessel. All patients received drug-eluting stents and were discharged on dual antiplatelet therapy with duration of at least on year.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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