Clinical Study of Coronary Extension Catheter
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coronary Extension Catheter.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Multicenter, Single-Arm Clinical Study Evaluating the Safety and Efficacy of Coronary Extension Catheter in Percutaneous Coronary Intervention
Overview
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
- Device Coronary Extension Catheter
For the subjects who met the requirements of the study protocol, the BM coronary extension catheter was used for treatment.
Primary outcome measures
- Device Delivery Success Rate [Time frame: Immediately after procedure, 0 day]
Secondary outcome measures (5)
- Procedural Success Rate [Time frame: Immediately after procedure, 0 day]
- Device Usage Evaluation [Time frame: Immediately after procedure, 0 day]
- Adverse events and serious adverse events related to the study device [Time frame: Endpoints will be measured through hospital discharge (expected to be within 7 days)]
- Adverse Event and Serious Adverse Event [Time frame: Endpoints will be measured through hospital discharge (expected to be within 7 days)]
- Device defects [Time frame: Immediately after procedure, 0 day]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Friendship Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT07742345 · BM-D28