Chronic Total Occlusion of Coronary Artery
Conditions
Keywords
chronic total occlusions, coronary artery
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.
Interventions
DEVICECoronary Crossing System of Shanghai MicroPort Rhythm
The mechanical vibration generated by the Coronary Crossing System through the piezoelectric effect is amplified and transmitted to the distal end of the guidewire to achieve high-frequency vibration at the tip of the guidewire, and then achieve efficient and safe penetration of the fibrous cap of the CTO.
Sponsors
Shanghai MicroPort Rhythm MedTech Co., Ltd.
Shanghai Zhongshan Hospital
Xiamen Cardiovascular Hospital, Xiamen University
Shanghai Baoshan District Wusong Central Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
The First Affiliated Hospital of Nanchang University
First Affiliated Hospital Xi'an Jiaotong University
First Affiliated Hospital of Wenzhou Medical University
Tianjin First Central Hospital
The Affiliated Hospital Of Southwest Medical University
Hebei General Hospital
First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
LanZhou University
Nanfang Hospital, Southern Medical University
The Second Affiliated Hospital of Dalian Medical University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
West China Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria: 1. Aged 18 years and older. 2. 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. 3. 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: 1. There is only one target CTO that needs to be treated with percutaneous coronary intervention (PCI). 2. Target CTO is located in a native coronary artery with a reference vessel diameter of ≥ 2.5 mm. 3. 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. 4. The target CTO occluded segment length ≥ 5 mm (visual inspection). 5. Angiography of the target CTO showed high density along the vessel, which is considered calcified lesion. 6. The antegrade approach is determined as the primary strategy with guidewire crossing in PCI treatment. 7. The fibrous cap of the target lesion can not be penetrated within 60 seconds using the guidewire with polypolymer coated or tip stiffness \> 1.5g (visual inspection) under fluoroscopy and the time is timed when the guidewire reaches the fibrous cap. (To identify chronic total occlusions and exclude acute or subacute occlusions that such guidewire can pass directly). 8. In addition to the target lesion, there must be up to one non-target lesion to be treated and it is located on a different epicardial vessel than the target lesion. Target lesions can be treated after successful treatment of the non-target lesion (residual stenosis \< 30% and TIMI 3 flow) without complications.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device success | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall device success | Baseline procedure | Overall device success is defined as successful crossing of the CTO, following use of the coronary crossing system during the procedure including antegrade or retrograde approach. |
| Technical Success | Baseline procedure | Technical success is defined as successful antegrade or retrograde crossing of the CTO into the true arterial lumen following advancement of at least 3 mm of the Coronary Crossing System into the proximal segment, with \<30% residual stenosis of the CTO after successful treatment with drug-eluting stents or drug-eluting balloons, with antegrade flow≥TIMI grade 2 in all branch vessels ≥ 2.5 mm in diameter distal to the CTO, as assessed by the core angiographic laboratory. |
| Procedural Success | Baseline procedure | Procedural success is defined as the achievement of Technical Success with freedom from device related MAEs as assessed by the Clinical Events Committee (CEC). |
| Clinical Success | 30 days post-procedure | Clinical success is defined as the achievement of Procedural Success with freedom from device related MAEs through 48 hours or hospital discharge and 30 days post index procedure as assessed by the Clinical Events Committee (CEC). |
| Freedom from device related major adverse event(MAE) | 48 hours or until discharge | Freedom from device related major adverse events (MAEs) at 48 hours or hospital discharge (whichever occurs first) post procedure, as assessed by Clinical Events Committee (CEC), defined as: * Cardiovascular related deaths * Myocardial Infarction. * Coronary Artery Perforation requiring treatment * Unscheduled cardiac surgery anytime between enrollment to completion of the study. * Intra-procedure stroke * Radiation exposure ≥ 8 Gy |
| Freedom from major adverse event(MAE) | 30 days post-procedure | Freedom from major adverse event(MAE) is defined as the freedom from device related MAE assessed through 30 days post-index procedure, as assessed by the Clinical Events Committee(CEC). |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJunbo Ge, M.D.
Fudan University
Outcome results
None listed