Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
Conditions
Keywords
Percutaneous Coronary Intervention (PCI)
Brief summary
This prospective, multicenter, single-arm study plans to enroll 69 subjects. Subjects meeting the protocol criteria will receive treatment with coronary extension catheters. The safety and efficacy of these catheters in percutaneous coronary intervention will be assessed through the collection and analysis of efficacy and safety endpoints during treatment and follow-up.
Interventions
DEVICECoronary Extension Catheter
For the subjects who met the requirements of the study protocol, the BM coronary extension catheter was used for treatment.
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
* Age ≥18 years, regardless of gender; * Patients suitable for percutaneous coronary intervention (PCI) and for whom the use of an extension catheter is planned to assist the intervention; * Ability to understand the purpose of the study, willingness to voluntarily participate, and ability to provide written informed consent.
Exclusion criteria
* Reference vessel diameter \< 2 mm; * Presence of thrombus in the target vessel; * Unprotected left main coronary artery disease; * Acute myocardial infarction occurring within 7 days prior to enrollment; * Known intolerance to anticoagulant or antiplatelet therapy, or known allergy to contrast media; * Concurrent severe hepatic or renal disease, or other severe systemic conditions that render the patient unsuitable for PCI; * Pregnant or lactating women; * Currently participating in another clinical trial of a drug or medical device without having reached the primary endpoint or completed the trial; * Any other condition that, in the investigator's opinion, makes the patient ineligible for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Delivery Success Rate | Immediately after procedure, 0 day | Device delivery success is defined as the successful delivery of the target device (balloon and/or stent) to the target lesion after the use of the study device during percutaneous coronary intervention (PCI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success Rate | Immediately after procedure, 0 day | Procedural success is defined as residual stenosis of the target lesion ≤30% (by visual estimation) and TIMI flow grade 3 after PCI. |
| Device Usage Evaluation | Immediately after procedure, 0 day | The device usage evaluation includes: pushability, support, overall ease of use, device trackability, and radiopacity. There are four grades, ranging from poor to excellent. |
| Adverse events and serious adverse events related to the study device | Endpoints will be measured through hospital discharge (expected to be within 7 days) | Adverse events and serious adverse events related to the study device during the study. |
| Adverse Event and Serious Adverse Event | Endpoints will be measured through hospital discharge (expected to be within 7 days) | Occurrence of adverse events and serious adverse events during the study. |
| Device defects | Immediately after procedure, 0 day | Incidence of device defects. |
Countries
China
Contacts
CONTACTSone, PhD
Outcome results
None listed