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

NCT05293002 | Active Not Recruiting DMC

• 1 other identifier: BARISTA protocol v3.0 20230405
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (3)

• Freedom from TLR

  Freedom from any Target Lesion Revascularization (TLR) at 12 months

  12 months

• Freedom from major amputation

  Freedom from amputation above the ankle

  12 months

• Freedom from restenosis

  No significant stenosis on duplex ultrasound (\>50% stenosis or systolic velocity ratio greater than 2.4)

  12 months

Secondary Outcomes (8)

• Technical success

  1 month

• Primary patency rate

  6, 12, and 24 months

• Stent graft occlusion rate

  1, 6, 12, and 24 months

• ABI

  6, 12, and 24 months

• Freedom from Target Lesion Revascularization

  12 and 24 months

Study Arms (1)

Restorer Iliac Stent System

EXPERIMENTAL

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

Device: Restorer Iliac Stent System

Interventions

Restorer Iliac Stent System DEVICE

Not applicable (only one intervention)

Restorer Iliac Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study.
• \. 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.
• \. 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.
• \. The target lesion has angiographic evidence of stenosis or restenosis \>50% or occlusion which can be passed with standard guidewire manipulation.
• \. There is angiographic evidence of a patent Common and Deep Femoral Artery.

Sponsors & Collaborators

• ID3 Medical: lead

Study Sites (14)

GZA ziekenhuizen

Antwerp, Antwerp, 2610, Belgium

Location

UZA

Antwerp, Antwerp, 2650, Belgium

Location

Jessa

Hasselt, Limburg, 3500, Belgium

Location

CHU Liège

Liège, Liège, 4000, Belgium

Location

AZ Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Vitaz

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

Location

AZ Sint Jan Brugge

Bruges, West-Vlaanderen, 8000, Belgium

Location

O.L.V. Hospital

Aalst, 9300, Belgium

Location

Imelda Hospital

Bonheiden, 2820, Belgium

Location

A.Z. Sint-Blasius

Dendermonde, 9200, Belgium

Location

Z.O.L.

Genk, 3600, Belgium

Location

az Groeninge

Kortrijk, Belgium

Location

R.Z. Heilig Hart

Tienen, 3300, Belgium

Location

A.Z. Jan Portaels

Vilvoorde, 1800, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: March 23, 2022
• Study Start: June 13, 2022
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (14)