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A First-in-Man Clinical Trial to Evaluate the Safety and Feasibility of ICS-Elpis in Patients With Iliac Artery Stenosis or Occlusion Lesions | Clinical Trials | Clareo Health

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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 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

NCT07290101•Biotyx Medical (Shenzhen) Co., Ltd.

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with stenosis or occlusion of the common iliac artery and/or external iliac artery caused by atherosclerosis.
•2. Age between 18 - 85 years old. Male or non-pregnant female.
•3. Patients with intermittent claudication (Rutherford category 2-3) or ischemic rest pain (Rutherford category 4).
•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.
•1. 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).
•2. The target lesion(s) can be successfully crossed with a guide wire and pre-dilated with an appropriately sized balloon.
•3. 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).
•4. 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).
•5. 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).
•6. 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.

Exclusion Criteria

•1. Patients with previously stented target lesion.
•2. 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.
•3. Patients with a history of or planned ipsilateral aortoiliac bypass surgery during the index procedure.
•4. Patients who were expected to undergo amputation of the target limb before the index procedure.
•5. Patients with an aneurysm, perforation and/or dissection of the target iliac artery before the index procedure.
•6. 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).
•7. Patients with acute myocardial infarction or angina pectoris within 30 days before the index procedure.
•8. 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.
•9. Patients with known intolerance to antiplatelet, anticoagulant, or thrombolytic medications.
•10. Patients with known diseases (not related to the trial) that require indefinite or lifelong anticoagulation therapy.
+13 more criteria

Locations (1)

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

December 8, 2025

Primary Completion Date

December 1, 2027

Completion Date

March 1, 2028

Last Updated

December 18, 2025

Enrollment

ESTIMATED participants

Conditions

Iliac Artery StenosisIliac Artery Occlusion

Interventions

Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System

DEVICE

Contacts

Ying Xia

CONTACT

0755-23221096 sophia.xia@biotyxmed.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A First-in-Man Clinical Trial to Evaluate the Safety and Feasibility of ICS-Elpis in Patients With Iliac Artery Stenosis or Occlusion Lesions

Inclusion Criteria

Exclusion Criteria

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