Clinical trial NCT02460042: Clinical Post Market Clinical Follow-up (PMCF) on Peripheral Arteries Treated With SeQuent® Please Over The Wire (OTW)
Official title: CONSEQUENT ALL COMERS Clinical PMCF on Peripheral Arteries Treated With SeQuent® Please OTW Paclitaxel Coated Balloon Catheter in an All Comer Patient Population
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Peripheral Arterial Occlusive Disease
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2015-06-02
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with peripheral artery occlusive disease (PAOD)

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)

Eligibility criteria: 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

Primary outcomes:
measure: Target Lesion Revascularization Rate
timeFrame: 12 months
Secondary outcomes:
measure: Target Lesion Revascularization Rate (TLR)
timeFrame: 24 months
measure: Procedural success
timeFrame: 1 day
measure: Ankle Brachial Index (ABI)
timeFrame: 12 months
measure: Ankle Brachial Index (ABI)
timeFrame: 24 months
measure: Ankle Brachial Index (ABI)
timeFrame: 3 years
measure: Ankle Brachial Index (ABI)
timeFrame: 5 years
measure: Maximum Walking Distance (MWD)
timeFrame: 12 months
measure: Maximum Walking Distance (MWD)
timeFrame: 24 months
measure: Maximum Walking Distance (MWD)
timeFrame: 3 years
measure: Maximum Walking Distance (MWD)
timeFrame: 5 years
measure: Patency rate
timeFrame: 12 months
measure: Patency rate
timeFrame: 24 months
measure: Patency rate
timeFrame: 3 years
measure: Patency rate
timeFrame: 5 years
measure: Rutherford classifications per group at all follow-up intervals
timeFrame: 12/24 months and 3/5 years
measure: Rutherford classification distribution change at all follow-up intervals
timeFrame: 12/24 months and 3/5 years
measure: Amputation rate
timeFrame: 12/24 months and 3/5 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: St. Gertrauden Krankenhaus
Study officials:
affiliation: St. Gertrauden Krankenhaus, Berlin, Germany
name: Ralf Langhoff, MD
role: PRINCIPAL_INVESTIGATOR
References: