Comparing two treatments for in-stent restenosis in carotid arteries
Official title: Comparison of Carotid Endarterectomy and Repeated Carotid Percutaneous Transluminal Angioplasty With or Without Stenting for In-stent Restenosis
Run by University Hospital Ostrava · NCT05390983 · Data updated 2026-11-12
This study is testing two different treatments for people with a blockage in their carotid artery to see which one works better and is safer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University Hospital Ostrava Academic / other |
| Locations | 1 site (Ostrava, Moravian-Silesian Region) |
| Status | Recruiting |
| Started | May 25, 2017 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | January 18, 2024 |
| Trial ID | NCT05390983 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-80 with 70-99% in-stent restenosis in the carotid artery who are functionally independent.
✕Probably not a fit
Patients with contraindications to general anesthesia or angiography, or those for whom the procedures are technically impossible, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study involves patients with in-stent restenosis in the carotid artery who are indicated for intervention. Participants will be randomly assigned to receive either repeated carotid percutaneous transluminal angioplasty with or without stenting or carotid endarterectomy with stent removal. The aim is to evaluate the safety and effectiveness of these two approaches in treating in-stent restenosis. The procedures will be performed under local anesthesia, and various techniques will be employed to ensure optimal outcomes.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment for patients with in-stent restenosis, potentially improving patient outcomes.
How similar studies have gone: While there have been studies comparing similar interventions, the specific focus on in-stent restenosis in this manner may provide novel insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * In-stent restenosis in carotid artery 70 - 99 % * Indication to carotid intervention * Age 18-80 years * Functionally independent with a modified Rankin score value of 0 - 2 points * Signed Informed consent Exclusion Criteria: * Contraindication to general anesthesia * Contraindication to angiography (iodine allergy, etc.) * Technically impossible to perform angioplasty with or without stenting * Participation in other clinical study within 60 days * Technically impossible to perform carotid endarterectomy
Where it's running
-
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia Recruiting
Study contacts
- Principal investigator: Tomas Hrbac, MD, PhD — University Hospital Ostrava
- Study coordinator: Tomas Hrbac, MD, PhD
- Email: tomas.hrbac@fno.cz
- Phone: +420597375402
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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SiroMax sirolimus-coated balloon for small coronary vessels with or without prior stents
A first-in-human test to see if the SiroMax drug-coated balloon can safely open narrow coronary arteries in adults with or without prior stents.
-
National registry of rapid unexplained coronary in‑stent restenosis (RECUR)
This nationwide registry will collect clinical and test data to see if patterns or biomarkers link to rapid unexplained in‑stent restenosis in adults with coronary stents.
-
Best way to fix under‑expanded coronary stents in resistant blockages
This compares intravascular lithotripsy (IVL) with high‑pressure or specialty balloons to see if IVL opens under‑expanded coronary stents better in people with in‑stent restenosis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.