Peripheral Arterial HemorrhageNCT07156409
The Clinical Application of Peripheral Embolization Coil Systems in Arteriovenous Embolization Within the Peripheral Vasculature
A study testing Peripheral Embolization Coil System in people with Peripheral Arterial Hemorrhage and Arteriovenous Malformation, run by Suzhou Zenith Vascular SciTech Limited.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Arterial Hemorrhage, Arteriovenous Malformation, Arteriovenous Fistula
- What is being tested?
- Peripheral Embolization Coil System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
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
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
Read the 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
- Conditions
- Peripheral Arterial Hemorrhage, Arteriovenous Malformation, Arteriovenous Fistula, Peripheral Aneurysm
- Being tested
- Peripheral Embolization Coil System
- Medical subject headings
- Arteriovenous Malformations, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Embolization Coil SystemDevice
Primarily used to block or reduce the blood flow velocity in the peripheral vascular system
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Embolization Coil System | Experimental | Not described Receives: Device: Peripheral Embolization Coil System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of technical success (embolization of target vessel)
Angiographic imaging confirmed successful occlusion of the target vessel segment with no blood perfusion.
Measured: Immediately after the intervention
Secondary outcomes (5)
Rate of treated vessel occlusion
Angiographic imaging confirmed successful occlusion of the target vessel segment with no blood perfusion.
Measured: 6 months
Target Vessel Re-intervention Rate
The embolized segment of the target vessel requires re-intervention/surgical intervention.
Measured: 30 days,3 months,6 months from procedure date
All-cause mortality rate
Death from any cause
Measured: 6 months from procedure date
Rate of Device/Procedure-Related Serious Adverse Events
Measured: Perioperative,30 days,3 months,6 months from procedure date
Adverse Event/Serious Adverse Event Rate
Measured: 6 months from procedure date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zenith Vascular SciTech Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156409
- Sponsor's protocol ID
- ZTHTL202501
- Status last verified
- Sep 2025
- First submitted
- 27 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07156409
- Acronym / sponsor ID
- ZTHTL202501
- Conditions
- Peripheral Arterial Hemorrhage, Arteriovenous Malformation, Arteriovenous Fistula, Peripheral Aneurysm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Suzhou Zenith Vascular SciTech LimitedIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Study start
- Sep 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral Embolization Coil System | Experimental | Device: Peripheral Embolization Coil System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral Embolization Coil SystemPrimarily used to block or reduce the blood flow velocity in the peripheral vascular system | Device | Peripheral Embolization Coil System |
Primary outcome
Rate of technical success (embolization of target vessel)
Time frame: Immediately after the intervention
Angiographic imaging confirmed successful occlusion of the target vessel segment with no blood perfusion.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral Embolization Coil System in people with Peripheral Arterial Hemorrhage and Arteriovenous Malformation, run by Suzhou Zenith Vascular SciTech Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of technical success (embolization of target vessel) (time frame: Immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.