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

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Peripheral Arterial Disease
• Interventions: Device: microcatheter

• Registration Number: NCT05747287
• Lead Sponsor: BrosMed Medical Co., Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-17
• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-02-28
• Primary Completion: 2023-10-03
• Study Completion: 2023-12-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age ≥ 18 years old;
2. Patients with symptomatic ischemic heart disease who are suitable for non-acute percutaneous coronary intervention (PCI);
3. 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;
4. 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

1. Patients with clinical symptoms consistent with ST-elevation myocardial infarction and/or ECG changes within 12 hours before the procedure;
2. Patients who are known to be intolerant to antiplatelet drugs or allergic to contrast media;
3. Patients with in-stent occlusion;
4. Patients with unprotected left main coronary artery disease;
5. Women who are pregnant or lactating;
6. Patients who are participating in clinical trials of other drugs or medical devices;
7. Patients with contraindications to the investigational device;
8. Other patients considered by the investigators to be unsuitable for this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	microcatheter	-

Primary Outcome Measures

Name	Time	Method
Technical success	0 day	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.

Secondary Outcome Measures

Name	Time	Method
Device success	0 day	Defined as delivery of the microcatheter to the designated site, assistence of guide wire into the target vessel, and successful withdrawal.
Procedural success	0 - 7 days	Defined as meeting all the following criteria: 1. After PCI, the final diameter stenosis of the target lesion achieves ≤30%, and the TIMI returns to grade 3; 2. 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.
Device super-selective angiography (if applicable)	0 day	the microcatheter shall deliver the contrast agent to the designated location and develop
Guide wire exchange supported (if applicable)	0 day	successful exchange of the guide wire
Device Performance Evaluation	0 day	The investigators will evaluate the device performance according to the use and operation of the device during the procedure

Trial Locations

Locations (3)

The Shijiazhuang People's Hospital; 🇨🇳 Shijiazhuang, Hebei, China

The Seventh People's Hospital of Zhengzhou; 🇨🇳 Zhengzhou, Henan, China

The Second Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China