Coronary Artery Disease, Peripheral Arterial Disease
Conditions
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.
Interventions
DEVICEmicrocatheter
supports the insertion of the guide wire，exchange of the guide wire and the delivery of contrast media
Sponsors
BrosMed Medical Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | 0 day | 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
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | 0 - 7 days | Defined as meeting all the following criteria: 1. After PCI, the final diameter stenosis of the target lesion achieves ≤30%, and the TIMI returns to grade 3; 2. 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) | 0 day | the microcatheter shall deliver the contrast agent to the designated location and develop |
| Guide wire exchange supported (if applicable) | 0 day | successful exchange of the guide wire |
| Device Performance Evaluation | 0 day | The investigators will evaluate the device performance according to the use and operation of the device during the procedure |
| Device success | 0 day | Defined as delivery of the microcatheter to the designated site, assistence of guide wire into the target vessel, and successful withdrawal. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of other adverse events and serious adverse events during the study | 0 - 7 days | — |
| Adverse events and serious adverse events related to the study device during the study | 0 - 7 days | — |
| Major adverse cardiac events (MACE) during the study | 0 - 7 days | Major adverse cardiac events (MACE) are defined as cardiac death, myocardial infarction, and target lesion revascularization (TLR). |
Countries
China
Outcome results
None listed