Other Clinical Trial - The SIR-POBA Bypass Trial

Status Active, not recruiting

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06056193
Study type	Interventional
Source	Paracelsus Medical University
Contact
Status	Active, not recruiting
Phase	N/A
Start date	September 20, 2023
Completion date	October 1, 2027

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05961943` - RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients	N/A
Completed	`NCT02900274` - "All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC for flOw liMiting Outcomes (LOCOMOTIVE Extended)
Withdrawn	`NCT01938924` - Surgical Revascularisation and Nerve Stimulation Trial	N/A
Completed	`NCT00740207` - Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral DSA	Phase 4
Recruiting	`NCT06082466` - FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial	N/A
Completed	`NCT05590182` - CO2-Angiography-Study to Evaluate Diagnostic and Safety to Patients With Peripher Arterial Stenotic or Occlusive Disease.	N/A
Recruiting	`NCT03638115` - The VaSecure BTK Study	N/A
Recruiting	`NCT01774058` - The Arterial Measurement of the Blood Flow Volume After Iloprost Stimulation	Phase 2
Active, not recruiting	`NCT00566436` - Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass	N/A
Active, not recruiting	`NCT00863967` - Early Detection of Arteriosclerosis	N/A
Recruiting	`NCT05586022` - Risk Factors for Adverse Outcomes of Endovascular Revascularization in Lower Extremity Arteriosclerosis Occlusion
Completed	`NCT02929095` - The Effect of Remifentanil-dexmedetomidine Compared With Remifentanil-midazolam on Patient's Satisfaction	N/A
Completed	`NCT02832570` - Sildenafil Efficacy Study on Time Walk From Peripheral Arterial Desease Patients (Stade II) With Arterial Claudication	Phase 3
Terminated	`NCT01341340` - The ABSORB BTK (Below The Knee) Clinical Investigation	N/A
Completed	`NCT02867501` - Venous Distension in Patients With Aneurysmatic Arterial Disease	N/A
Active, not recruiting	`NCT02460042` - Clinical Post Market Clinical Follow-up (PMCF) on Peripheral Arteries Treated With SeQuent® Please Over The Wire (OTW)
Completed	`NCT01855412` - Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes
Terminated	`NCT00717639` - Vasovist Magnetic Resonance Angiography (MRA) in Peripheral Arterial Occlusive Disease	Phase 4
Completed	`NCT00459888` - Cryoplasty CLIMB-registry	Phase 4
Suspended	`NCT00593762` - ASA- and Clopidogrel-Responsiveness in Patients With Peripheral Arterial Occlusive Disease and Interventional Procedures	N/A