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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)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug coated balloon angioplasty | Procedure | percutaneous transluminal angioplasty with peripheral balloon catheters |
| |
| SeQuent® Please OTW Paclitaxel Coated Balloon Catheter | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Revascularization Rate | rate of target lesion revascularization (interventional, surgical) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Revascularization Rate (TLR) | Target Lesion Revascularization Rate at 24 months* to establish a 'freedom from TLR' Kaplan-Meier curve | 24 months |
| Procedural success | Procedural success to pass and treat the lesions (remaining stenosis is 30 %) |
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Inclusion Criteria (patient):
Inclusion Criteria (lesion):
Exclusion Criteria (all comers):
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Patients with peripheral artery occlusive disease (PAOD)
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| Name | Affiliation | Role |
|---|---|---|
| Ralf Langhoff, MD | St. Gertrauden Krankenhaus, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Gertrauden Krankenhaus | Berlin | 10713 | Germany |
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| 1 day |
| Ankle Brachial Index (ABI) | ankle brachial index | 12 months |
| Ankle Brachial Index (ABI) | ankle brachial index | 24 months |
| Ankle Brachial Index (ABI) | ankle brachial index | 3 years |
| Ankle Brachial Index (ABI) | ankle brachial index | 5 years |
| Maximum Walking Distance (MWD) | maximum walking distance under standardized conditions | 12 months |
| Maximum Walking Distance (MWD) | maximum walking distance under standardized conditions | 24 months |
| Maximum Walking Distance (MWD) | maximum walking distance under standardized conditions | 3 years |
| Maximum Walking Distance (MWD) | maximum walking distance under standardized conditions | 5 years |
| Patency rate | Patency rates as observed using non-invasive Duplex ultrasound | 12 months |
| Patency rate | Patency rates as observed using non-invasive Duplex ultrasound | 24 months |
| Patency rate | Patency rates as observed using non-invasive Duplex ultrasound | 3 years |
| Patency rate | Patency rates as observed using non-invasive Duplex ultrasound | 5 years |
| Rutherford classifications per group at all follow-up intervals | Rutherford classifications per group at all follow-up intervals | 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 | 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 | 12/24 months and 3/5 years |
| ID | Term |
|---|---|
| C564658 | Peripheral Arterial Occlusive Disease 1 |
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