Clinical trial NCT05232760: SUPER-DIALYSIS-Study: Supera Stent Interventions in Juxta-anastomotic (re)Stenosis
Official title: SUPER-DIALYSIS-Study: Supera Stent Interventions in Juxta-anastomotic (re)Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stenosis of Arteriovenous Dialysis Fistula
Keywords: Juxta-anastomotic stenose of arteriovenous fistula
Lead sponsor: Klinikum Arnsberg
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hemodialysis patients from clinics with vascular centers

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 of the anastomosis.

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). Hemodialysis patients with failing radial-cephalic arteriovenous fistula (AVF) will receive treatment with the SUPERA stent and will be followed-up at 1, 3, 6 and 12 months after the procedure.

Eligibility criteria: Inclusion Criteria:

1. Patients must be ≥ 18 years of age, able to perform follow-up visits, have a life expectancy \> 12 months.
2. 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)
3. Patients with at least one previous endovascular intervention to restore AVF function
4. 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
5. The target blood vessel diameter of the target lesion is between 4.0 and 7.5 mm (in angiographic or ultrasound evaluation)
6. If there are other non-target lesions, then non-target lesions must be successfully cured with a balloon before treating the target lesion

Exclusion Criteria:

1. 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
2. Patients with a known hypersensitivity or contraindication to anticoagulant/anti-platelet therapies, or sensitivity to contrast media that cannot be adequately pre-medicated.
3. Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the study device.
4. 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.
5. Prior enrolment in this trial
6. Women who are pregnant or lactating
7. Patients, who underwent a major surgery (such as thoracotomy, craniotomy, etc.) within 30 days prior to the study.
8. Patients, who have scheduled a major surgery (such as thoracotomy, craniotomy, etc.). within 30 days after enrolment -

Primary outcomes:
measure: Number of patients with primary patency of juxta-anastomose at month 3
timeFrame: 3 months
Secondary outcomes:
measure: Number of patients with primary patency of juxta-anastomose
timeFrame: 1, 6 and 12 months.
measure: Number of patients with assisted primary patency
timeFrame: 1, 3, 6 and 12 months
measure: Number of patients with secondary patency
timeFrame: 1, 3, 6 and 12 months
measure: Number of patients with technical success
timeFrame: Day 1 after the index procedure
measure: Number of patients with procedural success
timeFrame: 1 day (discharge)
measure: Number of patients with clinical success
timeFrame: 1 day (discharge)
measure: Number of patients with access circuit patency
timeFrame: 1,3,6,12 months
measure: Recirculation rate
timeFrame: 1, 3, 6 and 12 months
measure: Fistula flow
timeFrame: 1, 3, 6 and 12 months
measure: Incidence of major adverse events
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Arnsberg
country: Germany
facility: Klinikum Hochsauerland GmbH
Study officials:
affiliation: Klinikum Hochsauerland GmbH
name: Michael Lichtenberg, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: