NCT05293002

Belgian Study to Assess the Efficacy and Safety of the RESTORER Iliac Stent for Treatment of Aorto-iliac Lesions.

Belgian Study to Assess the Efficacy and Safety of the RESTORER Iliac Stent System for the Treatment of Aorto-iliac Lesions (TASC A, B, C and D).

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (estimated)
• Sponsor: ID3 Medical · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The BARISTA study tests the safety and efficacy of the Restorer stent from the company iVascular. This stent is a medical device that is already approved for use in Europe, to treat stenotic (narrowed) iliac arteries. 200 Belgian patients from 13 different hospitals will be included in this study. Patients will be medically monitored for 2 years from the day of the study procedure. The treatment of the stenotic iliac arteries will be according to the standard of care, using the Restorer stent. This endovascular treatment consists of introducing the necessary materials in the blood vessels by a puncture in the groin under general or local anaesthesia, after which a thin plastic tube will be inserted into the femoral artery through the puncture site, until the stenotic iliac artery is reached. Medical imaging is done by angiography. The stenotic/occluded section of the artery will first be dilated by inserting and inflating a balloon. Next, the Restorer stent will be placed and, if necessary, another balloon may be inserted and inflated to allow the stent to fit nicely to the vessel wall and optimise the result. As per standard of care, follow-up will be done in the hospital after 1, 6, 12, and 24 months. During these visits, an ultrasound scan of the treated artery will be taken to evaluate the patency of the blood vessel. Also, two short questionnaires will be completed asking about the quality of life and walking difficulties. The use of medication will be recorded. If adverse events are experienced, they will be reported.

Detailed description

Prospective, single-arm, multicentre, physician-initiated clinical study to assess the long-term (up to 24 months) safety and efficacy of the RESTORER peripheral stent system (iVascular) for the treatment of iliac lesions in 200 subjects, in a controlled clinical setting post CE-certification when used according to the IFU with focus on the treatment of complex TASC A, B, C and D Aorto-iliac lesions. The primary endpoint of the study is freedom of any TLR, major amputation or restenosis (defined as significant stenosis on duplex ultrasound (\>50%, systolic velocity ratio greater than 2.4) within 12 months. Secondary endpoints are: technical success during procedure, and during the follow-up period: primary patency, stent graft occlusion rate, ABI, freedom from target lesion revascularization, clinical success (improvement of Rutherford classification), change in walking impairment questionnaire, change in quality of life questionnaire, freedom from above-the-ankle target limb amputation, and mortality. A subanalysis will be done to compare the results using the TASC classification, lesion location (AIE, AIC, bilateral, kissing configuration), gender, diabetes mellitus and Rutherford in terms of patency, frequency of TLR and clinical outcome at 12 and 24 months.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Restorer Iliac Stent System	Not applicable (only one intervention)

Timeline

• Start date: 2022-06-13
• Primary completion: 2025-07-31
• Completion: 2025-12-31
• First posted: 2022-03-23
• Last updated: 2024-10-16

Locations

14 sites across 1 country: Belgium