New coil device aims to stop bleeding without surgery
NCT ID NCT07156409
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a special coil device designed to block abnormal blood vessels in the arms or legs. The device is inserted through a small tube and placed into the target vessel to stop blood flow. About 139 people with conditions like bleeding, malformed vessels, or aneurysms will take part. The main goal is to see if the coil can successfully block the vessel safely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Peripheral Embolization Coil System (a device that blocks blood flow)
- What this could lead to
- If it works, this could provide a reliable, minimally invasive option to stop bleeding or treat abnormal blood vessels in the limbs without open surgery.
- What could go wrong
- This is an early-stage, single-arm study with no comparison group. The device may fail to block the vessel, require repeat procedures, or cause complications like blood clots or vessel damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 139 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18 to 75 years (inclusive), regardless of gender; 2. Patients diagnosed preoperatively via imaging (including but not limited to ultrasound, CTA, MRA, DSA, etc.) with peripheral arteriovenous conditions requiring embolization therapy; 3. The visually estimated normal reference diameter of the target vessel is ≥ 3mm; 4. 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: 1. The target vessel requires the concurrent use of other embolic materials (e.g., Gelfoam, embolic microspheres, liquid embolic agents, etc.); 2. Known definite history of allergy to platinum, tungsten metals, and/or any component of the investigational product; 3. Subjects with pre-existing severe cardiac, hepatic, renal, respiratory diseases, or coagulation disorders who are unsuitable for anesthesia or endovascular surgical treatment; 4. High-flow arteriovenous fistulas that may cause migration of the embolic material; 5. The target aneurysm is a blister aneurysm, dissecting aneurysm, mycotic (infectious) aneurysm, ruptured aneurysm, or aneurysm caused by connective tissue diseases; 6. 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; 7. The target vessel has undergone any previous embolization therapy or surgical intervention, or has recurrent disease; 8. Definite allergy, resistance, or contraindication to antiplatelet drugs, anticoagulants, contrast media, and/or anesthetics; 9. Females who are pregnant, breastfeeding, or planning to become pregnant within 6 months; males planning for parenthood within the next 6 months; 10. Subjects currently participating in other drug or device clinical trials who have not reached the trial endpoint; 11. Investigators deem the subject unsuitable for participation in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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