Status:
UNKNOWN
SUPER-DIALYSIS-Study: Supera Stent Interventions in Juxta-anastomotic (re)Stenosis
Lead Sponsor:
Klinikum Arnsberg
Conditions:
Stenosis of Arteriovenous Dialysis Fistula
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this exploratory study is to evaluate safety and effectiveness of treatment of juxta-anastomotic (re)stenosis with SUPERA stent by improving hemodynamic situation through obtuse shaping...
Detailed Description
Up to 50 patients undergoing percutaneous intervention due to juxta-anastomotic (re-)stenosis of the AV fistulas will be enrolled in this single-arm, prospective, multi-center CE marked study (IIT). H...
Eligibility Criteria
Inclusion
- Patients must be ≥ 18 years of age, able to perform follow-up visits, have a life expectancy \> 12 months.
- Hemodialysis patients undergoing endovascular angioplasty due to a clinically symptomatic stenosis (de novo or restenosis) of the juxta-anastomotic radiocephalic AVF with significant stenosis (lumen diameter \< 2.7mm)
- Patients with at least one previous endovascular intervention to restore AVF function
- The target lesion consists of one or more lesions with a target lesion length of less than or equal to 80 mm in the juxta-anastomotic segment of the radiocephalic AVF
- The target blood vessel diameter of the target lesion is between 4.0 and 7.5 mm (in angiographic or ultrasound evaluation)
- If there are other non-target lesions, then non-target lesions must be successfully cured with a balloon before treating the target lesion
Exclusion
- Patients with AVF stenosis observed and estimated as nonsignificant (lumen diameter \> 2.7mm) or a vessel \<4.0 and \> 7.5 mm in diameter by visual estimation
- Patients with a known hypersensitivity or contraindication to anticoagulant/anti-platelet therapies, or sensitivity to contrast media that cannot be adequately pre-medicated.
- Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the study device.
- Patients that are currently participating in another clinical trial involving any investigational drug or device that may potentially confound the results of the study, or that would limit the patient's compliance with the follow-up requirements of the study.
- Prior enrolment in this trial
- Women who are pregnant or lactating
- Patients, who underwent a major surgery (such as thoracotomy, craniotomy, etc.) within 30 days prior to the study.
- Patients, who have scheduled a major surgery (such as thoracotomy, craniotomy, etc.). within 30 days after enrolment -
Key Trial Info
Start Date :
March 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05232760
Start Date
March 17 2022
End Date
August 1 2024
Last Update
August 1 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Klinikum Hochsauerland GmbH
Arnsberg, Germany, 59759