The PRELUDE BTK Study
|ClinicalTrials.gov Identifier: NCT03693963|
Recruitment Status : Active, not recruiting
First Posted : October 3, 2018
Last Update Posted : April 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease Critical Limb Ischemia||Device: Serranator||Not Applicable|
Single arm, prospective, multi-center feasibility study enrolling up to 48 subjects with atherosclerotic lesions in the infrapopliteal arteries and/or Critical Limb Ischemia (CLI). The study will capture acute angiographic data to compare the pre-Serranator® inflation vs post inflation effects and will include 6 month clinical follow up.
The study population will consist of subjects with claudication or CLI, with de novo stenoses or non-stented restenotic or total occlusion lesions in infrapopliteal arteries having lesion length up to and including 12 cm in length and reference vessel diameter of 2.5 mm to 3.5 mm inclusive.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PRospective Study for the TrEatment of Atherosclerotic Lesions in the Infrapopliteal Arteries Using the Serranator® DevicE: PRELUDE BTK (Below The Knee) Study|
|Actual Study Start Date :||December 17, 2019|
|Actual Primary Completion Date :||April 11, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Single Arm, treated with Serranator
Subjects treated with Serrantor
The Serranator® PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.
- Incidence of MALE and POD (Safety) [ Time Frame: 30 days post procedure ]Composite of Major Adverse Limb Events (MALE) and Peri-procedural Death (POD), assessed at 30 days post procedure. MALE plus POD is defined as a composite of all cause death, thrombolysis/thrombectomy at the target lesion, open surgical revision or bypass, and major (above ankle) target limb amputation at 30 days post procedure. Safety will be evaluated on a per subject basis.
- Rate of Device Success (Procedural Efficacy) [ Time Frame: Immediately Post Serranator treatment ]Procedural efficacy will be assessed by the rate of device success defined as the achievement of successful insertion, balloon inflation and deflation, and removal of the study device(s) with a final diameter stenosis of <50% by visual assessment at the intended target site using only the Serranator device. Device success will be evaluated on a per lesion basis.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693963
|Medical University of Graz|
|Graz, Austria, A-8036|
|Klinikum Hochsauerland GmbH|
|Arnsberg, Germany, 59759|
|Buchholz, Germany, 21244|
|Imland Klinik Rendsburg|
|Rendsburg, Germany, 24768|
|Auckland City Hospital|
|Auckland, Grafton, New Zealand, 1023|
|Polsko-Amerykańskie Kliniki Serca PAKS|
|Chrzanów, Poland, 32-050|