PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia (PADI)
|Peripheral Vascular Disease||Device: PTA with placement of paclitaxel-eluting stent Device: PTA||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Percutaneous Transluminal Balloon Angioplasty (PTA) and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia|
- The primary endpoint will be primary patency of the treated site at 6 months. Primary patency is defined as <50% loss of luminal diameter at the treated site on CT arteriography (CTA) without re-intervention in the interim. [ Time Frame: 6 months ]
- Primary patency of the treated sites at 3, 6 and 12 months after intervention assessed by duplex sonography (binary patency, <50% stenosis defined as PSV ratio <2.0) [ Time Frame: 3, 6, 12 months ]
- Clinical evaluation of the treated ischemic leg at 3, 6 and 12 months. [ Time Frame: 3, 6, 12 months ]
- Major amputation (at or above the ankle) of the trial leg at 3, 6 and 12 months [ Time Frame: 3, 6, 12 months ]
- Minor amputation (below the ankle excluding the toes) of the trial leg at 3, 6 and 12 months. [ Time Frame: 3, 6, 12 months ]
- Infrapopliteal surgical bypass of the trial leg at 3, 6 and 12 months. [ Time Frame: 3, 6, 12 months ]
- Infrapopliteal endovascular re-intervention of the trial leg at 3, 6 and 12 months. [ Time Frame: 3, 6, 12 months ]
- Peri-procedural (within 30 days) complications. [ Time Frame: 30 days ]
- Death. [ Time Frame: 3, 6, 12 months ]
- Clinical assessment primarily by Rutherford score for peripheral arterial disease [ Time Frame: 2, 3, 4 and 5 years after treatment ]Clinical assessment outpatient clinic
- Target lesion patency by means of duplex sonography [ Time Frame: 2, 3, 4 and 5 years after treatment ]During outpatient clinic visits
- Major amputation (at or above the ankle) of treated limb [ Time Frame: yearly up to 10 years after treatment ]Assessment up to 5 years after treatment during outpatient clinic visits From 5 to 10 years by means of yearly evaluation of patient charts
- Minor amputation (below the ankle excluding the toes) of the trial leg at 3, 6 and 12 months. [ Time Frame: yearly up to 10 years after treatment ]From 2 to 5 years during outpatient clinic visits From 5 to 10 years yearly evaluation of patient charts
- Endovascular or surgical re-intervention of target lesion [ Time Frame: 3, 6, 12 months, 2,3,4 and 5 years after inclusion ]Follow-up until first re-intervention of target lesion
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||March 2023|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
PTA with primary placement of Drug (paclitaxel) Eluting Stent
Device: PTA with placement of paclitaxel-eluting stent
PTA with placement of paclitaxel-eluting stent
Active Comparator: 2
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.
Treatment of below the knee arterial lesions in patients with CLI with PTA and DES compared to only PTA.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471289
|Sint Antonius Ziekenhuis|
|Nieuwegein, Utrecht, Netherlands|
|HagaZiekenhuis, location Leyweg|
|The Hague, ZH, Netherlands, 2545CH|
|University Medical Center Utrecht (UMCU)|
|Utrecht, Netherlands, 3584 CX|
|Principal Investigator:||Hans Van Overhagen, MD PhD||HagaZiekenhuis Dept. of Radiology|