Peripheral Arterial Occlusive DiseaseNCT06056193
The SIR-POBA Bypass Trial
A study testing Balloon Angioplasty in people with Peripheral Arterial Occlusive Disease and Bypass Complication, run by Paracelsus Medical University at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Occlusive Disease, Bypass Complication, Femoropopliteal Artery Occlusion
- What is being tested?
- Balloon Angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- 20 Sep 2023to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or lactating women
- Active infection or sepsis
- Patients currently participating in another clinical trial
- Unconfirmed inflow
- Intolerance to sirolimus
- Coagulopathy
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- 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).
Trial locations and contacts
1 site in 1 country.
Austria1 site
University Hospital of Salzburg, Paracelsus Medical University
Salzburg, State of Salzburg, 5020
About this study
Official title: SIRrolimus-coated Versus Plain Old Balloon Angioplasty (POBA) in Lower Extremity Autologous Venous Bypass Stenosis - The SIR-POBA Bypass Trial
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.
Read the 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.
- Conditions
- Peripheral Arterial Occlusive Disease, Bypass Complication, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis, Critical Limb-Threatening Ischemia, Claudication, Intermittent
- Being tested
- Balloon Angioplasty
- Keywords
- Autologous Vein Bypass, Endovascular Revascularization
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon AngioplastyProcedure or surgery
Also called Endovascular Revascularization
Revascularisation procedures will be performed according to randomised list
| Study group | Role | What they receive |
|---|---|---|
| Plain Balloon Angioplasty | Active comparator | Plain Balloon Angioplasty will be used to treat lesions Receives: 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 Receives: Procedure: Balloon Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start20 Sep 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2027 (estimated)
Why it stopped: Limited recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Occlusive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- MedAlliance Swiss Medical Technology
- Responsible party
- Principal investigator, Manuela Pilz, Paracelsus Medical University
- Investigators
- Manuela Pilz, MD PD FEBVS, Principal investigator, Senior PhysicianKlaus Linni, MD PD FEBVS, Study director, Head of Division of Vascular and Endovascular SurgeryStephanie Rassam, MD, Study chair, Resident Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056193
- Sponsor's protocol ID
- 1036/2023
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIRrolimus-coated Versus Plain Old Balloon Angioplasty (POBA) in Lower Extremity Autologous Venous Bypass Stenosis - The SIR-POBA Bypass Trial
- ClinicalTrials.gov ID
- NCT06056193
- Acronym / sponsor ID
- 1036/2023
- Conditions
- Peripheral Arterial Occlusive Disease, Bypass Complication, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis, Critical Limb-Threatening Ischemia, Claudication, Intermittent
- Keywords
- Autologous Vein Bypass, Endovascular Revascularization
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Limited recruiting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Collaborators
- MedAlliance Swiss Medical Technology
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plain Balloon Angioplasty | Active comparator | Procedure: Balloon AngioplastyPlain Balloon Angioplasty will be used to treat lesions |
| Sirolimus-coated Balloon Angioplasty | Active comparator | Procedure: Balloon AngioplastySirolimus-coated Balloon Angioplasty will be used to treat lesions after preparing vessel with plain balloon angioplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Pregnant or lactating women
- Active infection or sepsis
- Patients currently participating in another clinical trial
- Unconfirmed inflow
- Intolerance to sirolimus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon AngioplastyAlso: Endovascular RevascularizationRevascularisation procedures will be performed according to randomised list | Procedure or surgery | Plain Balloon Angioplasty, Sirolimus-coated Balloon Angioplasty |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuela Pilz, MD PD FEBVS principal investigator
Senior Physician
Klaus Linni, MD PD FEBVS study director
Head of Division of Vascular and Endovascular Surgery
Stephanie Rassam, MD study chair
Resident Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon Angioplasty in people with Peripheral Arterial Occlusive Disease and Bypass Complication, run by Paracelsus Medical University at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Primary Lesion Target Patency of the venous bypass stenosis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.