Clinical Study of Coronary Extension Catheter
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrosMed Medical Co., Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Coronary Extension Catheter
DeviceFor the subjects who met the requirements of the study protocol, the BM coronary extension catheter was used for treatment.
Treatment groups
69 Participants
are divided into 1 treatment groupGroup A: test groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Device Delivery Success Rate
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).
Time frame
Immediately after procedure, 0 daySecondary outcomes
1
Procedural Success Rate
Procedural success is defined as residual stenosis of the target lesion ≤30% (by visual estimation) and TIMI flow grade 3 after PCI.
Time frame
Immediately after procedure, 0 day2
Device Usage Evaluation
The device usage evaluation includes: pushability, support, overall ease of use, device trackability, and radiopacity. There are four grades, ranging from poor to excellent.
Time frame
Immediately after procedure, 0 day3
Adverse events and serious adverse events related to the study device
Adverse events and serious adverse events related to the study device during the study.
Time frame
Endpoints will be measured through hospital discharge (expected to be within 7 days)4
Adverse Event and Serious Adverse Event
Occurrence of adverse events and serious adverse events during the study.
Time frame
Endpoints will be measured through hospital discharge (expected to be within 7 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov