The aim of the study is to assess the safety and efficacy of the paclitaxel-releasing balloon catheter SeQuent® Please OTW to treat de novo and restenotic lesions in peripheral arteries. It is the intention of this trial to treat suitable target lesions with drug coated balloon (DCB) only.
This study is an non-randomized, prospective, multi-center, non-interventional study (NIS=registry, for Germany: §23b MPG)
Study Type
OBSERVATIONAL
Enrollment
960
percutaneous transluminal angioplasty with peripheral balloon catheters
St. Gertrauden Krankenhaus
Berlin, Germany
Target Lesion Revascularization Rate
rate of target lesion revascularization (interventional, surgical)
Time frame: 12 months
Target Lesion Revascularization Rate (TLR)
Target Lesion Revascularization Rate at 24 months\* to establish a 'freedom from TLR' Kaplan-Meier curve
Time frame: 24 months
Procedural success
Procedural success to pass and treat the lesions (remaining stenosis is 30 %)
Time frame: 1 day
Ankle Brachial Index (ABI)
ankle brachial index
Time frame: 12 months
Ankle Brachial Index (ABI)
ankle brachial index
Time frame: 24 months
Ankle Brachial Index (ABI)
ankle brachial index
Time frame: 3 years
Ankle Brachial Index (ABI)
ankle brachial index
Time frame: 5 years
Maximum Walking Distance (MWD)
maximum walking distance under standardized conditions
Time frame: 12 months
Maximum Walking Distance (MWD)
maximum walking distance under standardized conditions
Time frame: 24 months
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Maximum Walking Distance (MWD)
maximum walking distance under standardized conditions
Time frame: 3 years
Maximum Walking Distance (MWD)
maximum walking distance under standardized conditions
Time frame: 5 years
Patency rate
Patency rates as observed using non-invasive Duplex ultrasound
Time frame: 12 months
Patency rate
Patency rates as observed using non-invasive Duplex ultrasound
Time frame: 24 months
Patency rate
Patency rates as observed using non-invasive Duplex ultrasound
Time frame: 3 years
Patency rate
Patency rates as observed using non-invasive Duplex ultrasound
Time frame: 5 years
Rutherford classifications per group at all follow-up intervals
Rutherford classifications per group at all follow-up intervals
Time frame: 12/24 months and 3/5 years
Rutherford classification distribution change at all follow-up intervals
Rutherford classification distribution change at all follow-up intervals
Time frame: 12/24 months and 3/5 years
Amputation rate
Amputation rate at 12/24 months and 3/5 years and 'freedom from amputation' Kaplan-Meier curve
Time frame: 12/24 months and 3/5 years