Trials Sponsors Conditions Drugs Pricing

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

microcatheterDevice

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

Experimental group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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);

Sponsors & Collaborators

BrosMed Medical Co., Ltd
Industrylead

Study Sites (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

MeSH Terms

Conditions

Coronary Artery DiseasePeripheral Arterial Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAtherosclerosisPeripheral Vascular Diseases

Enrollment

60 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (3)

Study Arms (1)

Experimental group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (3)

Study Arms (1)

Experimental group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations