Peripheral Arterial Occlusive Disease
Conditions
Brief summary
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
This study is an non-randomized, prospective, multi-center, non-interventional study (NIS=registry, for Germany: §23b MPG)
Interventions
PROCEDUREdrug coated balloon angioplasty
percutaneous transluminal angioplasty with peripheral balloon catheters
DEVICESeQuent® Please OTW Paclitaxel Coated Balloon Catheter
Sponsors
B. Braun Melsungen AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Revascularization Rate | 12 months | rate of target lesion revascularization (interventional, surgical) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | 1 day | Procedural success to pass and treat the lesions (remaining stenosis is 30 %) |
| Ankle Brachial Index (ABI) | 12 months | ankle brachial index |
| Maximum Walking Distance (MWD) | 12 months | maximum walking distance under standardized conditions |
| Target Lesion Revascularization Rate (TLR) | 24 months | Target Lesion Revascularization Rate at 24 months\* to establish a 'freedom from TLR' Kaplan-Meier curve |
| Rutherford classifications per group at all follow-up intervals | 12/24 months and 3/5 years | Rutherford classifications per group at all follow-up intervals |
| Rutherford classification distribution change at all follow-up intervals | 12/24 months and 3/5 years | Rutherford classification distribution change at all follow-up intervals |
| Amputation rate | 12/24 months and 3/5 years | Amputation rate at 12/24 months and 3/5 years and 'freedom from amputation' Kaplan-Meier curve |
| Patency rate | 12 months | Patency rates as observed using non-invasive Duplex ultrasound |
Countries
Germany
Outcome results
None listed