NCT00471289

PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia

Percutaneous Transluminal Balloon Angioplasty (PTA) and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Netherlands Society for Interventional Radiology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb ischemia compared to percutaneous transluminal balloon angioplasty (PTA).

Detailed description

Critical limb ischemia (CLI) is a serious condition that is becoming more and more common in the western world due to the growing percentage of elderly in the population and the rising incidence of diabetes. In about 40% of patients a stenosis or occlusion in the arteries below the level of the knee will be present. Restoration of blood flow is imperative to allow pain relief and tissue healing. Without revascularization patients with CLI are at risk for limb loss and potentially fatal complications such as sepsis. In patients treated with percutaneous transluminal balloon angioplasty (PTA)significant restenosis is found in approximately 50% after 6 months. In interventional cardiology a significant reduction in restenosis rates in coronary arteries has been found using drug eluting stents (DES), including the paclitaxel eluting stent (TAXUS, Boston Scientific). DES locally deliver drugs (e.g. paclitaxel) that interfere with the restenosis process. Using DES in treating below the knee (infrapopliteal) arterial lesions in patients with CLI may improve patency and clinical outcome. Comparison: Treatment of below the knee arterial lesions in patients with CLI with PTA and DES compared to only PTA.

Conditions

• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	PTA with placement of paclitaxel-eluting stent	PTA with placement of paclitaxel-eluting stent
DEVICE	PTA	PTA

Timeline

• Start date: 2007-08-01
• Primary completion: 2013-09-01
• Completion: 2023-03-01
• First posted: 2007-05-09
• Last updated: 2020-09-16

Locations

3 sites across 1 country: Netherlands