Clinical trial NCT03522038: Functional Assessment-guided Angioplasty in Patients With Coronary Chronic Total Occlusion
Official title: Functional Assessment-guided Angioplasty in Patients With Coronary Chronic Total Occlusion (FAGA-CTO)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Occlusion
Angioplasty, Balloon, Coronary
Keywords: coronary chronic total occlusion
functional evaluation
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline FFR at 6 months after CTO PCI
timeFrame: At baseline and 6 months after CTO PCI
measure: Change from Baseline FFR at 6 months after CTO PCI
timeFrame: At baseline and 6 months after CTO PCI
measure: Change from Baseline Myocardial perfusion at 6 months after CTO PCI
timeFrame: At baseline and 6 months after CTO PCI
measure: Change from Baseline Myocardial Viability at 6 months after CTO PCI
timeFrame: At baseline and 6 months after CTO PCI
Secondary outcomes:
measure: MACE
timeFrame: 6 months after CTO PCI
measure: In-stent restenosis
timeFrame: 6 months after CTO PCI
Other outcomes:
Locations:
Study officials:
References: