The Clinical Application of Peripheral Embolization Coil Systems in Arteriovenous Embolization Within the Peripheral Vasculature
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: Peripheral Embolization Coil System.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Hemorrhage, Arteriovenous Malformation, Arteriovenous Fistula, Peripheral Aneurysm. Basic parameters: 18 years — 75 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
- Center list to be confirmed — check the primary protocol.
- 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 Target Value Study Evaluating the Safety and Effectiveness of a Peripheral Embolization Coil System for the Treatment of Arteriovenous Embolization in the Peripheral Vasculature in a Real-World Setting
Overview
Evaluation of the Safety and Effectiveness of the Peripheral Embolization Coil System Manufactured by Suzhou Zhongtian Medical Instruments Co., Ltd. for the Treatment of Arteriovenous Embolization in the Peripheral Vasculature in a Real-World Setting
Detailed description
This study adopts a prospective, multicenter, single-arm target value design. It plans to enroll patients with peripheral arteriovenous diseases requiring embolization, who will be treated using the Peripheral Embolization Coil System manufactured by Suzhou Zhongtian Medical Instruments Co., Ltd. Follow-up assessments will be conducted during the procedure, prior to discharge, and at 30 days, 3 months, and 6 months post-operation to evaluate the safety and effectiveness of the Peripheral Embolization Coil System
Interventions
- Device Peripheral Embolization Coil System
Primarily used to block or reduce the blood flow velocity in the peripheral vascular system
Primary outcome measures
- Rate of technical success (embolization of target vessel) [Time frame: Immediately after the intervention]
Secondary outcome measures (5)
- Rate of treated vessel occlusion [Time frame: 6 months]
- Target Vessel Re-intervention Rate [Time frame: 30 days,3 months,6 months from procedure date]
- All-cause mortality rate [Time frame: 6 months from procedure date]
- Rate of Device/Procedure-Related Serious Adverse Events [Time frame: Perioperative,30 days,3 months,6 months from procedure date]
- Adverse Event/Serious Adverse Event Rate [Time frame: 6 months from procedure date]
Eligibility criteria
Inclusion criteria
- Aged 18 to 75 years (inclusive), regardless of gender;
- Patients diagnosed preoperatively via imaging (including but not limited to ultrasound, CTA, MRA, DSA, etc.) with peripheral arteriovenous conditions requiring embolization therapy;
- The visually estimated normal reference diameter of the target vessel is ≥ 3mm;
- Patients or their legally authorized representatives are capable of understanding the study objectives, voluntarily participating in this study, providing signed informed consent, and able to comply with follow-up.
Exclusion criteria
- The target vessel requires the concurrent use of other embolic materials (e.g., Gelfoam, embolic microspheres, liquid embolic agents, etc.);
- Known definite history of allergy to platinum, tungsten metals, and/or any component of the investigational product;
- Subjects with pre-existing severe cardiac, hepatic, renal, respiratory diseases, or coagulation disorders who are unsuitable for anesthesia or endovascular surgical treatment;
- High-flow arteriovenous fistulas that may cause migration of the embolic material;
- The target aneurysm is a blister aneurysm, dissecting aneurysm, mycotic (infectious) aneurysm, ruptured aneurysm, or aneurysm caused by connective tissue diseases;
- Severe vascular stenosis or tortuosity, or anatomical anomalies where it is anticipated that the device will be difficult to navigate to the lesion site, or other uncommon anatomies that may interfere with device use;
- The target vessel has undergone any previous embolization therapy or surgical intervention, or has recurrent disease;
- Definite allergy, resistance, or contraindication to antiplatelet drugs, anticoagulants, contrast media, and/or anesthetics;
- Females who are pregnant, breastfeeding, or planning to become pregnant within 6 months; males planning for parenthood within the next 6 months;
- Subjects currently participating in other drug or device clinical trials who have not reached the trial endpoint;
- Investigators deem the subject unsuitable 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
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07156409 · ZTHTL202501