Endovascular Treatment of Peripheral Artery Disease (PAD)
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|ClinicalTrials.gov Identifier: NCT03346577|
Recruitment Status : Terminated (Termination of collaboration)
First Posted : November 17, 2017
Last Update Posted : January 14, 2021
|Condition or disease||Intervention/treatment|
|Peripheral Arterial Disease Iliac Artery Disease Below-the-knee Obstruction Femoropopliteal Occlusive Disease||Device: stent or balloon|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||60 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Endovascular Treatment of Peripheral Artery Disease|
|Actual Study Start Date :||May 2, 2018|
|Actual Primary Completion Date :||October 1, 2020|
|Actual Study Completion Date :||October 1, 2020|
Patients with peripheral artery disease
located in the common and external iliac artery, the common and superficial femoral artery, the popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery).
Device: stent or balloon
Endovascular treatment with stent or balloon according to current practice
- Binary restenosis [ Time Frame: at 12 months follow-up ]Binary restenosis defined as ≥ 50% re-obstruction of the target lesion will be assessed by duplex ultrasound (peak systolic ratio >2.4)
- Device-related complications [ Time Frame: up to 12 months follow-up ]Registration of peri- and early/late postoperative complications
- Immediate procedural outcome [ Time Frame: up to 12 months follow-up ]
The combination of technical success defined as a successful access and deployment of the device and achievement of a final residual diameter stenosis of <30% of the treated target lesion on the procedural completion angiography.
and procedural success defined as a combination of technical success and absence of procedural complications.
- Clinical outcome [ Time Frame: at baseline ]Rutherford classification
- Clinical outcome [ Time Frame: at 6 weeks follow-up ]Rutherford classification
- Clinical outcome [ Time Frame: at 12 months follow-up ]Rutherford classification
- Primary sustained clinical improvement [ Time Frame: at 12 months follow-up ]defined as sustained upward shift of ≥ 1 category on Rutherford classification without the need for repeated TLR in surviving patients.
- Secondary sustained clinical improvement [ Time Frame: at 12 months follow-up ]defined as sustained upward shift of ≥ 1 category on Rutherford classification including the need for repeated TLR in surviving patients.
- Target lesion revascularization (TLR) [ Time Frame: up to 12 months follow-up ]defined as an endovascular or surgical treatment due to a problem arising from the lesion (+1cm proximally and distally to include edge phenomena).
- Mortality [ Time Frame: up to 12 months follow-up ]Procedure-related and all-cause mortality.
- Amputation [ Time Frame: up to 12 months follow-up ]minor amputation defined as below the ankle and major defined as above the ankle.
- Stent fracture [ Time Frame: up to 12 months follow-up ]Only if restenosis occurs, stent fracture will be examined (when Optimed Sinus Superflex 635 stent is used).
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): NCT03346577
|Overpelt, Limburg, Belgium, 3900|