The SIR-POBA Bypass Trial

• ClinicalTrials.gov Identifier: NCT06056193
• Recruitment Status: Active, not recruiting
• First Posted: September 28, 2023
• Last Update Posted: September 28, 2023
• Sponsor: Paracelsus Medical University
• Collaborator: MedAlliance Swiss Medical Technology
• Information provided by (Responsible Party): Manuela Pilz, Paracelsus Medical University

Study Description

Brief Summary:

The goal of this clinical trial is to compare plain old balloon angioplasty with sirolimus-coated balloon angioplasty in patients with an infrainguinal venous bypass stenosis. The main question we aim to answer is, how patency is affected by each of the randomised treatment options.

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Occlusive Disease; Bypass Complication; Femoropopliteal Artery Occlusion; Femoropopliteal Stenosis; Critical Limb-Threatening Ischemia; Claudication, Intermittent	Procedure: Balloon Angioplasty	Not Applicable

Detailed Description:

This clinical trial will be conducted at our Division of Vascular Surgery and Endovascular Surgery at the University Hospital of Salzburg. Patients will be randomized into one of the two treatment options (plain old ballon angioplasty versus sirolimus coated balloon angioplasty). The recruitment phase is calculated for two years with a planned follow-up of 2 years. Follow-up data will be collected to answer the endpoints and will include all available follow-ups to monitor the bypass up to 2 years after the procedure. Typically, follow-up visits will be conducted at 6 weeks, 3 months, 6 months, 12 months, and 24 months after the procedure.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: SIRrolimus-coated Versus Plain Old Balloon Angioplasty (POBA) in Lower Extremity Autologous Venous Bypass Stenosis - The SIR-POBA Bypass Trial
• Actual Study Start Date: September 20, 2023
• Estimated Primary Completion Date: October 1, 2025
• Estimated Study Completion Date: October 1, 2027

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Plain Balloon Angioplasty; Plain Balloon Angioplasty will be used to treat lesions	Procedure: Balloon Angioplasty; Revascularisation procedures will be performed according to randomised list; Other Name: Endovascular Revascularization
Active Comparator: Sirolimus-coated Balloon Angioplasty; Sirolimus-coated Balloon Angioplasty will be used to treat lesions after preparing vessel with plain balloon angioplasty	Procedure: Balloon Angioplasty; Revascularisation procedures will be performed according to randomised list; Other Name: Endovascular Revascularization

Outcome Measures

Primary Outcome Measures :

1. Incidence of Primary Lesion Target Patency of the venous bypass stenosis [ Time Frame: 2 years ]
   The incidence of patency will be analysed after reopening the stenosis of the venous bypass.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria

• Age at least 18 years
• Informed consent with signature
• Rutherford category 2 or 3 (in terms of lifestyle-limiting moderate or severe claudication symptomatology) or chronic critical ischemia (Rutherford 4-6)
• Venous bypass stenosis requiring intervention
• Confirmed inflow
• At least 1 crural outflow vessel

Exclusion Criteria:

• Pregnant or lactating women
• Active infection or sepsis
• Patients currently participating in another clinical trial
• Unconfirmed inflow
• Intolerance to sirolimus
• Coagulopathy
• Radiotherapy
• Patients on immunosuppressive therapy
• Non-dialysis renal insufficiency (eGFR < 45 ml/min/1.73m2)
• Use of potent CYP3A4 and/or P-gp inhibitors (such as ketoconazole, Voriconazole, itraconazole, erythromycin, telithromycin, or clarithromycin) or strong CYP3A4 and/or P-gp inducers (such as rifampin or rifabutin).

Contacts and Locations

Locations

Austria

University Hospital of Salzburg, Paracelsus Medical University

Salzburg, Austria, 5020

Sponsors and Collaborators

Paracelsus Medical University

MedAlliance Swiss Medical Technology

Investigators

• Principal Investigator: Manuela Pilz, MD PD FEBVS; Senior Physician
• Study Director: Klaus Linni, MD PD FEBVS; Head of Division of Vascular and Endovascular Surgery
• Study Chair: Stephanie Rassam, MD; Resident Physician

More Information

• Responsible Party: Manuela Pilz, Senior Physician, Paracelsus Medical University
• ClinicalTrials.gov Identifier: NCT06056193
• Other Study ID Numbers: 1036/2023
• First Posted: September 28, 2023
• Last Update Posted: September 28, 2023
• Last Verified: September 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Manuela Pilz, Paracelsus Medical University:

Autologous Vein Bypass; Endovascular Revascularization

Additional relevant MeSH terms:

Intermittent Claudication; Arterial Occlusive Diseases; Constriction, Pathologic; Ischemia; Pathological Conditions, Anatomical; Pathologic Processes; Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases