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NCT05293002: BARISTA
Belgian Study to Assess the Efficacy and Safety of the RESTORER Iliac Stent for Treatment of Aorto-iliac Lesions.
NA trial testing Restorer Iliac Stent System in Peripheral Arterial Disease in 131 participants. Participants enrolled and being followed up; not accepting new ones.
31 July 2025
Quick facts
| Lead sponsor | ID3 Medical |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 131 |
| Start date | 13 June 2022 |
| Primary completion | 31 July 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 14 locations across Belgium |
Drugs / interventions tested
- Restorer Iliac Stent System
Conditions studied
- Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →
Sponsor
ID3 Medical
Who can join
18 and older, female only, with Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05293002
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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- NCT07076082 — Vascular Trial Associated Registry Pilot · Phase 4 · recruiting
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Other ID3 Medical trials
Trials by the same sponsor.
- NCT04635501 — AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial · NA · completed
- NCT03845543 — Belgian-Italian Trial to Evaluate the Efficacy and Safety of Below The Knee (BTK) Treatment With the Luminor 14 Paclitax · NA · completed
- NCT03368144 — Belgian Trial Evaluating the ClearLumen II Peripheral Thrombectomy System Recanalization of (sub)acute Thrombotic Femoro · NA · completed
- NCT03349996 — Belgian Trial Investigating the LifeStream Stent in Complex TASC C and D Iliac Lesions · NA · completed
- NCT03347383 — Clinical Trial Investigating the Combination Therapy With Luminor DCB and iVolution Stent in TASC C and D Femoropoplitea · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05293002 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ID3 Medical
- Last refreshed: 16 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05293002.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing