Comparing two treatments for in-stent restenosis in carotid arteries
Comparison of Carotid Endarterectomy and Repeated Carotid Percutaneous Transluminal Angioplasty With or Without Stenting for In-stent Restenosis
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital Ostrava Academic / other |
| Locations | 1 site (Ostrava, Moravian-Silesian Region) |
| Trial ID | NCT05390983 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with 70-99% in-stent restenosis in the carotid artery who are functionally independent.
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.
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 performed: While there have been studies comparing similar interventions, the specific focus on in-stent restenosis in this manner may provide novel insights.
Eligibility criteria
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 this trial is running
Ostrava, Moravian-Silesian Region
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.