Clinical trial NCT06056193: The SIR-POBA Bypass Trial
Official title: SIRrolimus-coated Versus Plain Old Balloon Angioplasty (POBA) in Lower Extremity Autologous Venous Bypass Stenosis - The SIR-POBA Bypass Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Occlusive Disease
Bypass Complication
Femoropopliteal Artery Occlusion
Femoropopliteal Stenosis
Critical Limb-Threatening Ischemia
Claudication, Intermittent
Keywords: Autologous Vein Bypass
Endovascular Revascularization
Lead sponsor: Paracelsus Medical University
Sponsor class: OTHER
Collaborators: name: MedAlliance Swiss Medical Technology
First posted: 2023-09-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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).

Primary outcomes:
measure: Incidence of Primary Lesion Target Patency of the venous bypass stenosis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: University Hospital of Salzburg, Paracelsus Medical University
Study officials:
affiliation: Senior Physician
name: Manuela Pilz, MD PD FEBVS
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of Division of Vascular and Endovascular Surgery
name: Klaus Linni, MD PD FEBVS
role: STUDY_DIRECTOR
affiliation: Resident Physician
name: Stephanie Rassam, MD
role: STUDY_CHAIR
References: