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

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

Overview

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.

Interventions

• Device Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System
  Subjects in the arm will be treated with ICS-Elpis

Primary outcome measures

• Primary Efficacy Endpoint: Primary Patency Rate of the Target Lesion [Time frame: At12 months]
• 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)]

Eligibility criteria

Inclusion criteria

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

• 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.

Exclusion criteria

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.
• 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.

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

Device feasibility

Study locations

China · 1 center

• Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT07290101 · ICS-FIM

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗