The SIR-POBA Bypass Trial

NCT06056193 | Withdrawn

• 1 other identifier: 1036/2023
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Occlusive Disease; Bypass Complication; Femoropopliteal Artery Occlusion; Femoropopliteal Stenosis; Critical Limb-Threatening Ischemia; Claudication, Intermittent

Keywords

Autologous Vein Bypass; Endovascular Revascularization

Outcome Measures

Primary Outcomes (1)

• Incidence of Primary Lesion Target Patency of the venous bypass stenosis

  The incidence of patency will be analysed after reopening the stenosis of the venous bypass.

  2 years

Study Arms (2)

Plain Balloon Angioplasty

ACTIVE COMPARATOR

Plain Balloon Angioplasty will be used to treat lesions

Procedure: Balloon Angioplasty

Sirolimus-coated Balloon Angioplasty

ACTIVE COMPARATOR

Sirolimus-coated Balloon Angioplasty will be used to treat lesions after preparing vessel with plain balloon angioplasty

Procedure: Balloon Angioplasty

Interventions

Balloon Angioplasty PROCEDURE

Revascularisation procedures will be performed according to randomised list

Also known as: Endovascular Revascularization

Plain Balloon Angioplasty; Sirolimus-coated Balloon Angioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Paracelsus Medical University: lead
• MedAlliance Swiss Medical Technology: collaborator

Study Sites (1)

University Hospital of Salzburg, Paracelsus Medical University

Salzburg, Salzburg, 5020, Austria

Location

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1; Intermittent Claudication

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Manuela Pilz, MD PD FEBVS

  Senior Physician

  PRINCIPAL INVESTIGATOR

• Klaus Linni, MD PD FEBVS

  Head of Division of Vascular and Endovascular Surgery

  STUDY DIRECTOR

• Stephanie Rassam, MD

  Resident Physician

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: September 20, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 29, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)