SUPER-DIALYSIS-Study: Supera Stent Interventions in Juxta-anastomotic (re)Stenosis

Stenosis of Arteriovenous Dialysis Fistula Clinical Trial

Official title:

SUPER-DIALYSIS-Study: Supera Stent Interventions in Juxta-anastomotic (re)Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05232760
• Other study ID #: ASL202002
• Status: Recruiting
• Start date: March 17, 2022
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Klinikum Arnsberg
• Contact: Michael Lichtenberg, Dr.med.
• Phone: +49 02923 952 242
• Email: M.Lichtenberg[@]klinikum-hochsauerland.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Constriction, Pathologic
• Fistula
• Stenosis of Arteriovenous Dialysis Fistula

Intervention

Device:
• Supera™ Peripheral Stent System
The device will be employed for treatment of juxta-anastomotic stenosis in failing AV fistula after previous percutaneous angioplasty procedures

Locations

Country	Name	City	State
Germany	Klinikum Hochsauerland GmbH	Arnsberg

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Arnsberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with primary patency of juxta-anastomose at month 3	Primary patency is defined as clinically assessed intervention free (IFP) period	3 months
Secondary	Number of patients with primary patency of juxta-anastomose	Primary patency is defined as clinically assessed intervention free (IFP) period	1, 6 and 12 months.
Secondary	Number of patients with assisted primary patency	Assisted primary patency is defined as interval until access thrombosis or the time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to maintain the functionality of a patent access	1, 3, 6 and 12 months
Secondary	Number of patients with secondary patency	Secondary patency is defined as interval until access abandonment, thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to reestablish functionality in thrombosed access	1, 3, 6 and 12 months
Secondary	Number of patients with technical success	Residual stenosis < 30% after treatment with Supera stent (measured by angiography during the procedure)	Day 1 after the index procedure
Secondary	Number of patients with procedural success	Residual stenosis < 30% with no major adverse events (MAE)	1 day (discharge)
Secondary	Number of patients with clinical success	Hemodialysis access function improved, dialysis function restored, and at least one dialysis session completed after the procedure until discharge	1 day (discharge)
Secondary	Number of patients with access circuit patency	Freedom from development of a stenosis in any region of the AVF circuit, including the juxta-anastomotic segment	1,3,6,12 months
Secondary	Recirculation rate		1, 3, 6 and 12 months
Secondary	Fistula flow	Flow in AV fistula measured with ultrasound	1, 3, 6 and 12 months
Secondary	Incidence of major adverse events	Major adverse events (death, stroke)	6 and 12 months