Study Comparing Legflow Versus Bare Balloon Angioplasty for Treatment of Atherosclerotic Disease
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|ClinicalTrials.gov Identifier: NCT02710656|
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : January 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis||Device: Legflow® balloon Device: Standard PTA||Not Applicable|
This interventional study will collect data about the treatment of de novo lesions or restenotic lesions. Restenotic lesions that are previously DCB (drug coated balloon) treated or in-stent restenosis are excluded in this study.
The primary objective of this randomized study is to compare the efficacy of the DCB (Legflow - Cardionovum) versus POBA for the treatment of de novo lesions or restenosis in the SFA and in the popliteal artery (segment P1 -P2) by assessing the binary restenosis rate with duplex ultrasonography at 12 months.
The secondary endpoints are the assessment of the immediate procedural outcome, distribution of Rutherford, mortality, target lesion revascularization (TLR), target extremity revascularization (TER), amputation and anklebrachial index (ABI).
For each patient enrolled, data will be collected up to 12 months after the procedure.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Randomized Controlled Trial Comparing Legflow - DCB (Cardionovum) Versus Bare Balloon Angioplasty for the Treatment of Atherosclerotic Disease in the Superficial Femoral & Popliteal Segment|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||October 2019|
|Actual Study Completion Date :||November 2019|
Experimental: Drug Coated Balloon (DCB) - Legflow®
Percutaneous balloon angioplasty performed with the investigational device, the paclitaxel eluting Legflow® balloon.
Device: Legflow® balloon
Percutaneous angioplasty performed with a Drug coated balloon (DCB) with Paclitaxel
Other Name: Paclitaxel eluting balloon
Active Comparator: Standard PTA - POBA
Percutaneous balloon angioplasty performed with the clinical standard, that is, a non-drug eluting balloon (POBA, plain old balloon angioplasty).
Device: Standard PTA
Percutaneous angioplasty performed with a standard balloon
Other Name: POBA
- Efficacy measured by binary restenosis rate [ Time Frame: Until 12 months after procedure ]Binary restenosis rate determined by duplex ultrasonography at 1, 6 and 12 months afte procedure. Binary restenosis is defined as a re-obstruction ≥50% of the target lesion (peak systolic velocity ratio > 2.4).
- Immediate procedural outcome of percutaneous balloon angioplasty [ Time Frame: From start of procedure surgery until completion of procedure surgery (Percutaneous balloon angioplasty) ]Investigator opinion of procedural and technical success of the percutaneous angioplasty. Opinion of investigator (yes/no) is recorded in the CRF for technical success and procedural success.
- Rutherford [ Time Frame: Baseline until 12 months after procedure ]Distribution of Rutherford stages during follow-up as compared to baseline.
- Mortality [ Time Frame: Until 12 months after procedure ]30-day mortality, 6-months mortality and overall mortality at 12 months.
- Repeated target lesion revascularization (TLR) rate [ Time Frame: Until 12 months after procedure ]TLR is defined as a repeated procedure (endovascular or surgical) due to a problem arising from the lesion (+1 cm proximally and distally to include edge phenomena) initially treated in surviving patients with preserved limb.
- Repeated target extremity revascularization (TER) rate [ Time Frame: Until 12 months after procedure ]TER is defined as a procedure (endovascular or surgical) due to a problem arising in the ipsilateral traject (iliac, femoropopliteal and below the knee arteries) remote from the lesion initially treated in surviving patients with preserved limb.
- Minor and major amputation rate [ Time Frame: Until 12 months after procedure ]Occurrence of minor (below the ankle) and major (above the ankle) amputations.
- Ankle-Brachial Index (ABI) [ Time Frame: Baseline until 12 months after procedure ]Reporting of Ankle-Brachial Index compared to baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710656
|Antwerpen, Belgium, 2060|
|Brugge, Belgium, 8000|
|ZOL (Ziekenhuis Oost-Limburg)|
|Genk, Belgium, 3600|
|Hasselt, Belgium, 3500|
|Leuven, Belgium, 3000|
|Bordeau, France, 33076|
|Principal Investigator:||Peter Goverde, Dr.||ZNA Stuivenberg|