A Prospective, Multicenter Clinical Trial in Evaluating the Safety and Efficacy of the Coronary Crossing System in Patients With Coronary Chronic Total Occlusions
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Total Occlusion of Coronary Artery
- Sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd.
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Device success
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary crossing system for the treatment of patients with coronary chronic total occlusions.
Detailed Description
This study is divided into two phases. The first phase is the pilot study stage, which is a prospective single-group observational test (FIM phase). The second phase is the pivotal study phase, which is a prospective, multi-center, single-group clinical trial (OPC phase). It is carried out in about 20 hospitals in China. 1. Pilot study phase (FIM phase): It is a prospective single-group observational test. It is expected to recruit 10 subjects in a research center in China. 2. Pivotal study phase (OPC phase): It is a prospective, multicenter, single-group clinical trial. 146 subjects are expected to be recruited in 20 research centers in China. 3. All subjects with coronary chronic total occlusions participating in this clinical study must have only a CTO lesion which occluded in length of more than 5 mm and located in a native coronary artery with a diameter of ≥ 2.50 mm (visual inspection). 4. All subjects receive clinical follow-up during hospitalization, 30 days after surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical Inclusion Criteria:
- •Aged 18 years and older.
- •Subjects with coronary artery disease who have symptoms of angina pectoris and evidence of ischemia or myocardial viability in the area innervated by the coronary arteries where the CTO is located.
- •Subjects who are able to understand the purpose of the trial, participate voluntarily or by proxy and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up.
- •Angiography Inclusion Criteria:
- •There is only one target CTO that needs to be treated with percutaneous coronary intervention (PCI).
- •Target CTO is located in a native coronary artery with a reference vessel diameter of ≥ 2.5 mm.
- •Angiography showed complete occlusion of the target CTO (visual inspection), antegrade flow of the occluded vessel segment TIMI grade 0 and inferred occlusion time ≥ 3 months; or previous angiographic records confirmed occluded time of the target CTO ≥ 3 months.
- •The target CTO occluded segment length ≥ 5 mm (visual inspection).
- •Angiography of the target CTO showed high density along the vessel, which is considered calcified lesion.
Exclusion Criteria
- •General Exclusion Criteria:
- •Acute myocardial infarction within 30 days prior to baseline procedure.
- •Life expectancy \< 1 year.
- •Inability to use protocol-required concomitant medications (eg, aspirin, P2Y12 platelet receptor inhibitors, heparin, contrast agents, etc) due to allergy or other contraindications, and no alternative medications.
- •The target CTO has an iatrogenic dissection that occurred within the past 3 months.
- •Left ventricular ejection fraction less than 35%.
- •Severe aortic or mitral valve disease.
- •Planned left ventricular (LV) support device during CTO PCI.
- •Subjects with clear bleeding tendency, contraindications to antiplatelet agents and anticoagulant therapy.
- •Stroke, transient ischemic attack (TIA), or significant gastrointestinal (GI) bleeding within 6 months before the baseline procedure.
Outcomes
Primary Outcomes
Device success
Time Frame: Baseline procedure
Device success is defined as successful antegrade crossing of the CTO into the true arterial lumen distal to the occlusion following advancement of at least 3 mm of the Coronary Crossing System into any segment as assessed by the core angiographic laboratory. (An antegrade only approach may involve Antegrade Dissection Re-Entry (ADR) with or without the use of specialized devices (e.g. Stingray); absence of successful retrograde crossing of a collateral will still be considered an antegrade only approach.)
Secondary Outcomes
- Overall device success(Baseline procedure)
- Technical Success(Baseline procedure)
- Procedural Success(Baseline procedure)
- Clinical Success(30 days post-procedure)
- Freedom from device related major adverse event(MAE)(48 hours or until discharge)
- Freedom from major adverse event(MAE)(30 days post-procedure)