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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Peripheral Arterial Disease
• Intervention / Treatment: Device: microcatheter

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China
      • The Shijiazhuang People's Hospital
  • Henan
    • Zhengzhou, Henan, China
      • The Seventh People's Hospital of Zhengzhou
  • Shaanxi
    • Xi'an, Shaanxi, China
      • The Second Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Device: microcatheter; supports the insertion of the guide wire，exchange of the guide wire and the delivery of contrast media

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac events (MACE) during the study	Major adverse cardiac events (MACE) are defined as cardiac death, myocardial infarction, and target lesion revascularization (TLR).	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

Collaborators and Investigators

• Sponsor: BrosMed Medical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Actual): October 3, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Coronary Disease; Coronary Artery Disease; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: S02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No