Iliac Artery StenosisNCT07290101
A First-in-Man Clinical Trial to Evaluate the Safety and Feasibility of ICS-Elpis in Patients With Iliac Artery Stenosis or Occlusion Lesions
A study testing Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System in people with Iliac Artery Stenosis and Iliac Artery Occlusion, run by Biotyx Medical (Shenzhen) Co., Ltd. at 1 site in China.
Trial summary
This trial is a prospective, single-center, first-in-man clinical trial to evaluate the feasibility, preliminary safety and effectiveness of the Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System. 15 subjects are intended to be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Iliac Artery Stenosis, Iliac Artery Occlusion
- What is being tested?
- Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2025to 1 Mar 2028
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General inclusion criteria
- Patients with stenosis or occlusion of the common iliac artery and/or external iliac artery caused by atherosclerosis.
- Age between 18 - 85 years old. Male or non-pregnant female.
- Patients with intermittent claudication (Rutherford category 2-3) or ischemic rest pain (Rutherford category 4).
- Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to complete the follow-up according to the protocol requirements.
- Angiographic Inclusion Criteria
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- Patients with evidence of unilateral or bilateral de novo or restenosis (non-stent treatment) lesion(s) in the common iliac artery and/or external iliac artery, with the stenosis degree of the target lesion being≥50% (including occlusion).
- The target lesion(s) can be successfully crossed with a guide wire and pre-dilated with an appropriately sized balloon.
- The target lesion(s) with reference vessel diameter between 4.0 mm and 12.0 mm, and total length of unilateral lesion(s) ≤ 100 mm (tandem lesions are allowed).
- Up to two ipsilateral target lesions or bilateral lesions are allowed (one target lesion per limb, with the length adhering to the unilateral criterion). Up to two stents are allowed for stent overlap per side (i.e., a maximum of two stents can be implanted per side).
- Patients with angiographic evidence of patent outflow vessels in the target limb, including: a healthy common femoral artery (<50% stenosis); at least one of the deep femoral artery or superficial femoral artery is patent (<50% stenosis); a healthy popliteal artery (<50% stenosis); and at least one patent infrapopliteal vessel connected (<50% stenosis).
- For stenotic or occlusive target lesion(s) located at the ostium of the common iliac artery without a residual stump, intervention can be achieved through kissing stent technique.
Who cannot join
- General exclusion criteria
- Patients with previously stented target lesion.
- Patients who have undergone lower extremity arterial intervention within 30 days before the index procedure, or has such intervention planned for within 30 days after the index procedure.
- Patients with a history of or planned ipsilateral aortoiliac bypass surgery during the index procedure.
- Patients who were expected to undergo amputation of the target limb before the index procedure.
- Patients with an aneurysm, perforation and/or dissection of the target iliac artery before the index procedure.
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- Patients who have undergone coronary artery intervention within 30 days before the index procedure, or has such intervention planned for within 30 days after the index procedure (including the index procedure).
- Patients with acute myocardial infarction or angina pectoris within 30 days before the index procedure.
- Patients with a stroke within 3 months before the index procedure, or a stroke more than 3 months before the index procedure accompanied by severe paralysis and aphasia sequelae.
- Patients with known intolerance to antiplatelet, anticoagulant, or thrombolytic medications.
- Patients with known diseases (not related to the trial) that require indefinite or lifelong anticoagulation therapy.
- Patients with known allergies to aspirin, heparin, clopidogrel, contrast agent, poly(lactide), iron and its degradation products.
- Patients with a history of iron overload or iron disorder, such as hereditary hemochromatosis, etc.
- Patients with coagulation insufficiency (platelet count < 80*109/L), systemic coagulation disorders or hypercoagulable tendencies.
- Patients with severe hepatic or renal insufficiency (serum creatinine >2 times the upper limit of normal or on renal dialysis; ALT or AST > 5 times the upper limit of normal).
- Patients with a life expectancy of less than two years.
- Patient currently participating in another clinical trial, and have not yet completed that trial.
- Patients who are not suitable for participating the trial as per investigator judgement.
- Angiographic Exclusion Criteria
- Patients with angiographic evidence of thrombus within or adjacent to the target lesion(s).
- Patients with a history of ipsilateral iliac artery stenting, where the distance between the previously implanted stent and the current target lesion is ≤ 5 mm.
- Patients with coexisting ipsilateral iliac aneurysms or abdominal aortic aneurysms.
- Patients in whom the internal iliac artery is patent, but implanting the stent in the target lesion will block the blood flow from entering the internal iliac artery.
- Patients requiring placement of a study device within 2 cm proximal to the inguinal ligament.
- Patients with severe calcification of the target lesion which makes it impossible for the pre-dilation balloon to reach its nominal diameter.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200120
Meng Ye, PHD
About this study
Official title: A Prospective, Single-Center, First-in-Man Clinical Trial to Evaluate the Safety and Feasibility of the Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System in Patients With Iliac Artery Stenosis or Occlusion Lesions
This trial is a prospective, single-center, first-in-man clinical trial to evaluate the feasibility, preliminary safety and effectiveness of the Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System. 15 subjects are intended to be enrolled.
Read the detailed description
Clinical follow-up visits should be conducted at before discharge, 30 days, 6 month, 9 months, and 12 months post-procedure. CTA and DUS will be performed at 6 month and 12 months post-procedure.
The primary endpoints include primary patency rate of the target lesion at 12 months post-procedure and Major Adverse Events (MAE) at 9 months post-procedure.
- Conditions
- Iliac Artery Stenosis, Iliac Artery Occlusion
- Being tested
- Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System
- Keywords
- iliac artery occlusion, Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System, iliac artery stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioresorbable Peripheral Balloon-Expandable Covered Scaffold SystemDevice
Subjects in the arm will be treated with ICS-Elpis
| Study group | Role | What they receive |
|---|---|---|
| ICS-Elpis | Experimental | Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System Receives: Device: Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint: Primary Patency Rate of the Target Lesion
Primary patency is defined as the peak systolic velocity ratio (PSVR) ≤2.4 assessed by duplex ultrasonography (DUS) or the stenosis degree of the target lesion≤70% assessed by CTA; if there is a conflict between the results of DUS and CTA, the CTA result should prevail.
Measured: At12 months
Primary Safety Endpoint: Rate of Major Adverse Events
The endpoint is a composite endpoint includes
- Device or procedure-related death within 30 days
- Myocardial Infarction (MI) within 30 days,
- Target lesion revascularization (TLR) within 9 months,
- Major amputation above the ankle joint of the target limb, resulting from a vascular event within 9 months.
Measured: At 30 days (for death and MI) and 9 months (for TLR and major amputation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start8 Dec 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliac Artery StenosisStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290101
- Sponsor's protocol ID
- ICS-FIM
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, First-in-Man Clinical Trial to Evaluate the Safety and Feasibility of the Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System in Patients With Iliac Artery Stenosis or Occlusion Lesions
- ClinicalTrials.gov ID
- NCT07290101
- Acronym / sponsor ID
- ICS-FIM
- Conditions
- Iliac Artery Stenosis, Iliac Artery Occlusion
- Keywords
- iliac artery occlusion, Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System, iliac artery stenosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 18 Dec 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.
This trial is a prospective, single-center, first-in-man clinical trial to evaluate the feasibility, preliminary safety and effectiveness of the Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System. 15 subjects are intended to be enrolled.
Detailed description
Clinical follow-up visits should be conducted at before discharge, 30 days, 6 month, 9 months, and 12 months post-procedure. CTA and DUS will be performed at 6 month and 12 months post-procedure.
The primary endpoints include primary patency rate of the target lesion at 12 months post-procedure and Major Adverse Events (MAE) at 9 months post-procedure.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICS-Elpis | Experimental | Device: Bioresorbable Peripheral Balloon-Expandable Covered Scaffold SystemBioresorbable Peripheral Balloon-Expandable Covered Scaffold System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- General inclusion criteria
- Patients with stenosis or occlusion of the common iliac artery and/or external iliac artery caused by atherosclerosis.
- Age between 18 - 85 years old. Male or non-pregnant female.
- Patients with intermittent claudication (Rutherford category 2-3) or ischemic rest pain (Rutherford category 4).
- Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to complete the follow-up according to the protocol requirements.
Key exclusion criteria (25 listed)
- General exclusion criteria
- Patients with previously stented target lesion.
- Patients who have undergone lower extremity arterial intervention within 30 days before the index procedure, or has such intervention planned for within 30 days after the index procedure.
- Patients with a history of or planned ipsilateral aortoiliac bypass surgery during the index procedure.
- Patients who were expected to undergo amputation of the target limb before the index procedure.
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 |
|---|---|---|
| Bioresorbable Peripheral Balloon-Expandable Covered Scaffold SystemSubjects in the arm will be treated with ICS-Elpis | Device | ICS-Elpis |
Primary outcome
Primary Efficacy Endpoint: Primary Patency Rate of the Target Lesion
Time frame: At12 months
Primary patency is defined as the peak systolic velocity ratio (PSVR) ≤2.4 assessed by duplex ultrasonography (DUS) or the stenosis degree of the target lesion≤70% assessed by CTA; if there is a conflict between the results of DUS and CTA, the CTA result should prevail.
Primary Safety Endpoint: Rate of Major Adverse Events
Time frame: At 30 days (for death and MI) and 9 months (for TLR and major amputation)
The endpoint is a composite endpoint includes 1. Device or procedure-related death within 30 days 2. Myocardial Infarction (MI) within 30 days, 3. Target lesion revascularization (TLR) within 9 months, 4. Major amputation above the ankle joint of the target limb, resulting from a vascular event within 9 months.
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 18 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System in people with Iliac Artery Stenosis and Iliac Artery Occlusion, run by Biotyx Medical (Shenzhen) Co., Ltd. at 1 site in China.
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 12 inclusion and 25 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 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Ying Xia (0755-23221096, sophia.xia@biotyxmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint: Primary Patency Rate of the Target Lesion (time frame: At12 months). The study lists 2 primary outcomes in all. 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 18 Dec 2025.