Trial for A Novel Facilitated Antegrade Steering Technique in Revascularization of Coronary Chronic Total Occlusions
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|ClinicalTrials.gov Identifier: NCT03901079|
Recruitment Status : Terminated (HGRAC approval letter had expired. The enrollment speed of FAST CTO is much slower than planning and the scientific value becomes limited due to the delayed data readout anticipation.)
First Posted : April 3, 2019
Last Update Posted : December 11, 2020
|Condition or disease||Intervention/treatment|
|CAD||Other: single-arm study|
All subjects who are candidates for percutaneous coronary intervention (PCI), signed the informed consent form and had chronic total coronary occlusion (CTO) lesion will be evaluated for enrollment in this study.At least 100 subjects will be enrolled. Each site will be allowed to enroll up to a maximum of 25 subjects.
Primary Effectiveness Endpoint:
Technical Success: the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a CTO lesion in the true vessel lumen/within the collaterals in those cases that were otherwise refractory to treatment with a currently marketed guidewire
Primary Safety Endpoint:
30-day MACE rate for CTO cases in which the BridgePoint Medical System was used.
MACE is defined as the composite of cardiac death, Q-wave and non-Q-wave myocardial infarction(MI), and any ischemia-driven target lesion revascularization(TLR).
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||A Prospective, Multi-center, Non-Randomized Controled Trial for A Novel Facilitated Antegrade Steering Technique in Revascularization of Coronary Chronic Total Occlusions In Chinese Population--FAST CTO China|
|Actual Study Start Date :||October 8, 2018|
|Actual Primary Completion Date :||August 31, 2020|
|Actual Study Completion Date :||December 3, 2020|
CTO BridgePoint system
BridgePoint CTO System:
Other: single-arm study
- Assess efficacy of BridgePoint CTO system in recanalization of CTO lesions resistant to conventional wire approach (ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a CTO lesion) [ Time Frame: during the procedure ]the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a CTO lesion in the true vessel lumen/within the collaterals in those cases that were otherwise refractory to treatment with a currently marketed guidewire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901079
|Fuwai Hospital, Cams&Pumc|
|Beijing, Beijing, China, 100037|
|West China Hospital Sichuan University|
|Chengdu, Sichuan, China, 610041|
|Principal Investigator:||Yuejin Yang, Doc.||FUWAI HOSPITAL, CAMS&PUMC|