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

NCT05747287 | Completed

• 1 other identifier: S02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Device success

  0 day

• Procedural success

  0 - 7 days

• Device super-selective angiography (if applicable)

  0 day

• Guide wire exchange supported (if applicable)

  0 day

• Device Performance Evaluation

  0 day

Other Outcomes (3)

• Major adverse cardiac events (MACE) during the study

  0 - 7 days

• Adverse events and serious adverse events related to the study device during the study

  0 - 7 days

• Occurrence of other adverse events and serious adverse events during the study

  0 - 7 days

Study Arms (1)

Experimental group

EXPERIMENTAL

Device: microcatheter

Interventions

microcatheter DEVICE

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BrosMed Medical Co., Ltd: lead

Study Sites (3)

The Shijiazhuang People's Hospital

Shijiazhuang, Hebei, China

Location

The Seventh People's Hospital of Zhengzhou

Zhengzhou, Henan, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Atherosclerosis; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: February 28, 2023
• Study Start: January 17, 2023
• Primary Completion: October 3, 2023
• Study Completion: December 22, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)