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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05747287
• Other study ID #: S02
• Status: Completed
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: December 22, 2023

Study information

• Verified date: January 2024
• Source: BrosMed Medical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 22, 2023
• Est. primary completion date: October 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• microcatheter
supports the insertion of the guide wire,exchange of the guide wire and the delivery of contrast media

Locations

Country	Name	City	State
China	The Shijiazhuang People's Hospital	Shijiazhuang	Hebei
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	The Seventh People's Hospital of Zhengzhou	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
BrosMed Medical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Adverse events and serious adverse events related to the study device during the study		0 - 7 days
Other	Occurrence of other adverse events and serious adverse events during the study		0 - 7 days
Primary	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	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
Secondary	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
Secondary	Device super-selective angiography (if applicable)	the microcatheter shall deliver the contrast agent to the designated location and develop	0 day
Secondary	Guide wire exchange supported (if applicable)	successful exchange of the guide wire	0 day
Secondary	Device Performance Evaluation	The investigators will evaluate the device performance according to the use and operation of the device during the procedure	0 day