PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the Serranator DevicE (PRELUDE)
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|ClinicalTrials.gov Identifier: NCT03001700|
Recruitment Status : Completed
First Posted : December 23, 2016
Last Update Posted : April 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: Serranator™ Alto PTA Serration Balloon Catheter||Not Applicable|
Single Arm, prospective, OUS multi-center feasibility study enrolling up to 30 subjects with superficial femoral or popliteal lesions. The study will capture acute angiographic data to compare the pre- Serranator™ inflation vs post inflation effects.
The study population will consist of subjects with claudication or ischemic rest pain, with de novo or non-stented restenotic lesions in femoropopliteal arteries having lesion length less than or equal to 10 cm, total occlusion up to 6 cms in length and reference vessel diameter of 4 mm to 6 mm, inclusive.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the Serranator DevicE: PRELUDE Study|
|Actual Study Start Date :||February 1, 2017|
|Actual Primary Completion Date :||May 31, 2017|
|Actual Study Completion Date :||December 31, 2017|
Subjects will be treated with the Serranator™ Alto PTA Serration Balloon Catheter device
Device: Serranator™ Alto PTA Serration Balloon Catheter
The Serranator™ is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.
- To evaluate the technical feasibility of using the Serranator™ Alto PTA Serration Balloon Catheter during the endovascular treatment of critical SFA or popliteal artery lesions. [ Time Frame: Through Study Completion, approximately 6 months ]
- OCT and/or IVUS imaging post use of the Serranator to document evidence of vessel wall serrations in a sub-set of up to 10 subjects. [ Time Frame: Through Study Completion, approximately 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001700
|Medizinische Universtität Graz|
|Graz, Austria, A-8036|
|Auckland City Hospital|
|Auckland, Grafton, New Zealand, 1023|
|Polsko-Amerykańskie Kliniki Serca PAKS Małopolskie Centrum Sercowo Naczyniowe|
|Chrzanow, Poland, 32-050|
|Szpital Uniwersytecki w Krakowie Pracownia Angiografii Oddział Angiologii|
|Krakow, Poland, 31-066|