The SIR-POBA Bypass Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-20

Study Completion Date

2027-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plain Balloon Angioplasty

Plain Balloon Angioplasty will be used to treat lesions

Group Type ACTIVE_COMPARATOR

Balloon Angioplasty

Intervention Type PROCEDURE

Revascularisation procedures will be performed according to randomised list

Sirolimus-coated Balloon Angioplasty

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

Group Type ACTIVE_COMPARATOR

Balloon Angioplasty

Intervention Type PROCEDURE

Revascularisation procedures will be performed according to randomised list

Interventions

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Balloon Angioplasty

Revascularisation procedures will be performed according to randomised list

Intervention Type PROCEDURE

Other Intervention Names

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Endovascular Revascularization

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No