Clinical Post Market Clinical Follow-up (PMCF) on Peripheral Arteries Treated With SeQuent® Please Over The Wire (OTW)

Study Overview
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Brief Summary
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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.

Detailed Description
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This study is an non-randomized, prospective, multi-center, non-interventional study (NIS=registry, for Germany: §23b MPG)

Official Title
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CONSEQUENT ALL COMERS Clinical PMCF on Peripheral Arteries Treated With SeQuent® Please OTW Paclitaxel Coated Balloon Catheter in an All Comer Patient Population

Conditions
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Peripheral Arterial Occlusive Disease

Intervention / Treatment
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* Procedure: drug coated balloon angioplasty
* Device: SeQuent® Please OTW Paclitaxel Coated Balloon Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (patient): Willingness to treat the target lesion according to the DCB only concept Patients in Rutherford classes 2 through 5 Patients eligible for peripheral revascularization by means of Percutaneous Transluminal Angioplasty (PTA) Patients must be 18 years of age Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol Patients must agree to undergo at least the 12-month clinical follow-up Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon angioplasty by means of the paclitaxel-eluting PTA-balloon catheter or other suitable devices. Patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document. Inclusion Criteria (lesion): Peripheral lesions in peripheral arteries above and below the knee with reference vessel diameters between 1.5 and 8.0 mm, lesion lengths ≥ 2 cm and ≤ 27 cm as angiographically documented* Diameter stenosis pre-procedure must be 70% Target lesion above and below the knee Vessels must have adequate runoff with at least one vessel to the foot. *Lesions separated by less than 2 cm are considered as one lesion Exclusion Criteria (all comers): Patient not suitable for revascularization by interventional means

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: drug coated balloon angioplasty|percutaneous transluminal angioplasty with peripheral balloon catheters|
|Device: SeQuent® Please OTW Paclitaxel Coated Balloon Catheter|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Revascularization Rate | rate of target lesion revascularization (interventional, surgical) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 %) | 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 |