Evaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions

Study Overview
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Brief Summary
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This is a prospective, multi-center, single-group post-market study. It is planned to be carried out in about 3 clinical institutions, and a total of 60 subjects are expected to be enrolled.

Official Title
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A Post-Market Study to Evaluate the Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions

Conditions
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Coronary Artery Disease, Peripheral Arterial Disease

Intervention / Treatment
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* Device: microcatheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old; Patients with symptomatic ischemic heart disease who are suitable for non-acute percutaneous coronary intervention (PCI); Patients with target lesion diameter stenosis ≥ 70% (visually) or de novo coronary chronic total occlusion (CTO), or tortuous lesions, who plan to use Pronavi Microcatheter; Patients or their guardians who understand the purpose of the trial, voluntarily participate and sign the written informed consent, and are able to be followed up. Exclusion Criteria: Patients with clinical symptoms consistent with ST-elevation myocardial infarction and/or ECG changes within 12 hours before the procedure; Patients who are known to be intolerant to antiplatelet drugs or allergic to contrast media; Patients with in-stent occlusion; Patients with unprotected left main coronary artery disease; Women who are pregnant or lactating; Patients who are participating in clinical trials of other drugs or medical devices; Patients with contraindications to the investigational device; Other patients considered by the investigators to be unsuitable for this trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Device: microcatheter<br>* supports the insertion of the guide wire，exchange of the guide wire and the delivery of contrast media<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Defined as successful guide wire passage, that is, the Pronavi Microcatheter successfully supports the guide wire through the target lesion to reach the distal true coelom. | 0 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success | Defined as delivery of the microcatheter to the designated site, assistence of guide wire into the target vessel, and successful withdrawal. | 0 day | 
| Procedural success | Defined as meeting all the following criteria: After PCI, the final diameter stenosis of the target lesion achieves ≤30%, and the TIMI returns to grade 3; No all-cause death, Q-wave myocardial infarction, stroke, cardiac tamponade, target vessel revascularization (including re-PCI or emergency coronary artery bypass grafting) before discharge. | 0 - 7 days | 
| Device super-selective angiography (if applicable) | the microcatheter shall deliver the contrast agent to the designated location and develop | 0 day | 
| Guide wire exchange supported (if applicable) | successful exchange of the guide wire | 0 day | 
| Device Performance Evaluation | The investigators will evaluate the device performance according to the use and operation of the device during the procedure | 0 day |