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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-13

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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Peripheral Arterial Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All patients will receive the Restorer stent of iVascular according to the IFU. Prospective, single-arm, multicentre, physician-initiated clinical study to assess the safety and efficacy of the study device during a two year FU period.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Restorer Iliac Stent System

RESTORER Iliac Stent system for the treatment of Aorto-iliac lesions (TASC A, B, C and D) according to IFU

Group Type EXPERIMENTAL

Restorer Iliac Stent System

Intervention Type DEVICE

Not applicable (only one intervention)

Interventions

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Restorer Iliac Stent System

Not applicable (only one intervention)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

2\. Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study.

3\. Patient presenting with a stenotic or occlusive lesion at the Aorto-iliac arteries suitable for stenting with the Restorer stent (iVascular) (on indication for primary stenting, based on the discretion of the investigator). This lesion is corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions.

4\. Estimated life expectancy ≥ 2 years. 5. Patient presenting a score from 2 to 4 following Rutherford classification. 6. Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study.

7\. The target lesion has angiographic evidence of stenosis or restenosis \>50% or occlusion which can be passed with standard guidewire manipulation.

8\. There is angiographic evidence of a patent Common and Deep Femoral Artery.

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