Back to resultsEvaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions
Primary Purpose
Coronary Artery Disease, Peripheral Arterial Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
microcatheter
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- The Shijiazhuang People's Hospital
- The Seventh People's Hospital of Zhengzhou
- The Second Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Device success
Defined as delivery of the microcatheter to the designated site, assistence of guide wire into the target vessel, and successful withdrawal.
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.
Device super-selective angiography (if applicable)
the microcatheter shall deliver the contrast agent to the designated location and develop
Guide wire exchange supported (if applicable)
successful exchange of the guide wire
Device Performance Evaluation
The investigators will evaluate the device performance according to the use and operation of the device during the procedure
Full Information
NCT ID
NCT05747287
First Posted
February 17, 2023
Last Updated
February 17, 2023
Sponsor
BrosMed Medical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05747287
Brief Title
Evaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions
Official Title
A Post-Market Study to Evaluate the Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BrosMed Medical Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
microcatheter
Intervention Description
supports the insertion of the guide wire，exchange of the guide wire and the delivery of contrast media
Primary Outcome Measure Information:
Title
Technical success
Description
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.
Time Frame
0 day
Secondary Outcome Measure Information:
Title
Device success
Description
Defined as delivery of the microcatheter to the designated site, assistence of guide wire into the target vessel, and successful withdrawal.
Time Frame
0 day
Title
Procedural success
Description
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.
Time Frame
0 - 7 days
Title
Device super-selective angiography (if applicable)
Description
the microcatheter shall deliver the contrast agent to the designated location and develop
Time Frame
0 day
Title
Guide wire exchange supported (if applicable)
Description
successful exchange of the guide wire
Time Frame
0 day
Title
Device Performance Evaluation
Description
The investigators will evaluate the device performance according to the use and operation of the device during the procedure
Time Frame
0 day
Other Pre-specified Outcome Measures:
Title
Major adverse cardiac events (MACE) during the study
Description
Major adverse cardiac events (MACE) are defined as cardiac death, myocardial infarction, and target lesion revascularization (TLR).
Time Frame
0 - 7 days
Title
Adverse events and serious adverse events related to the study device during the study
Time Frame
0 - 7 days
Title
Occurrence of other adverse events and serious adverse events during the study
Time Frame
0 - 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deng Jie
Phone
029-87679000
Email
jie.deng@mail.xjtu.edu.cn
Facility Information:
Facility Name
The Shijiazhuang People's Hospital
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mi jie
Facility Name
The Seventh People's Hospital of Zhengzhou
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niu Siquan
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deng Jie
Phone
029-87679000
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions
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