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

NCT ID: NCT05747287

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-17
• Study Completion Date: 2023-12-22

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.

Conditions

Coronary Artery Disease; Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Group Type: EXPERIMENTAL

microcatheter

Intervention Type: DEVICE

supports the insertion of the guide wire，exchange of the guide wire and the delivery of contrast media

Interventions

microcatheter

supports the insertion of the guide wire，exchange of the guide wire and the delivery of contrast media

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BrosMed Medical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

China

Other Identifiers

S02

Identifier Type: -

Identifier Source: org_study_id