Active — Not RecruitingNot Applicable

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

Belgium131 participantsStarted 2022-06-13

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 1. Males or non-pregnant females ≥ 18 years of age at the time of consent. Females of childbearing potentials have a negative pregnancy test \<7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female participants will be exempted from this requirement in case they are sterile, infertile or have been post-menopausal for at least 12 months. 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. \- Exclusion Criteria: 1. …

What they're measuring

Freedom from TLR

Timeframe: 12 months

Freedom from major amputation

Timeframe: 12 months

Freedom from restenosis

Timeframe: 12 months

Trial details

NCT IDNCT05293002

SponsorID3 Medical

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31

View on ClinicalTrials.gov More Peripheral Arterial Disease trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.