The PRELUDE BTK Study

NCT03693963 | Completed FDA Device

• 1 other identifier: CSP-0197
• Study Type: interventional
• Target: 49
• Locations: 4 countries
• Sites: 6

Brief Summary

The objective of the PRELUDE BTK study is to assess safety and efficacy of the Serranator® PTA Serration Balloon Catheter (study device) in subjects with atherosclerotic peripheral artery disease of the infrapopliteal arteries.

Conditions

Peripheral Arterial Disease; Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• Incidence of MALE and POD (Safety)

  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.

  30 days post procedure

Secondary Outcomes (1)

• Rate of Device Success (Procedural Efficacy)

  Immediately Post Serranator treatment

Study Arms (1)

Single Arm, treated with Serranator

OTHER

Subjects treated with Serrantor

Device: Serranator

Interventions

Serranator DEVICE

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.

Single Arm, treated with Serranator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female of \>18 years old.
• Women of child bearing potential must have a negative urine pregnancy test within 7 days of index procedure.
• Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and comply with all follow-up visits and has signed the consent form.
• Subject is eligible for standard surgical repair in target limb if necessary.
• Subject has Rutherford Clinical Category 3, 4 or 5. Enrollment of Rutherford 3 will be limited to no more than 40% of total subjects.
• Estimated life expectancy \> 1 year.
• Target lesion(s) has stenosis \>70% by visual assessment;
• De-novo, or non-stented re-stenotic lesions;
• Reference vessel diameter is between 2.5 mm and 3.5 mm, inclusive;
• Target lesions involve infra-popliteal tibial arteries above the tibio-talar joint;
• Up to two target lesion(s) may be treated. These target lesions may be located in a single or two infrapopliteal arteries;
• A target lesion may consist of one long or multiple serial lesions that are up to and including 12 cm in length that can be covered by a single balloon (longest balloon length for this study will be 12 cm);
• If two critical lesions are identified in two vessels and both qualify for the study, the investigator may treat both lesions with investigational balloons or may choose to identify one lesion as the target lesion and treat the second lesion with commercial devices except atherectomy;
• If two critical lesions are in one vessel and both lesions qualify for the study, both lesions should be treated with investigational balloons. Lesions that are within 3 cm of each other will be treated as a single lesion;
• Target vessel(s) reconstituted at or above the ankle with inline flow to at least one patent inframalleolar outflow vessel in each target vessel. If the peroneal artery is the treated artery, it should supply collaterals at the ankle that reconstitute an inframalleolar outflow vessel;

You may not qualify if:

• Rutherford Clinical Category 1, 2, or 6
• Evidence of aneurysm or acute thrombus in the target vessel.
• Subjects with previous bypass surgery in lower target extremity.
• Planned major amputation (above the ankle) of either limb.
• Subject has significant stenosis or occlusion of inflow tract not successfully treated (\>30% residual stenosis and/or significant complication of the procedure).
• History of any open surgical procedure within the past 30 days.
• Planned endovascular procedure within 14 days prior to the BTK procedure, except to treat the inflow vessels on the day of the procedure, or a planned endovascular or open surgical procedure within the next 30 days after the BTK procedure on either limb.
• Planned intervention of occluded or stenotic pedal arteries at the time of the index procedure.
• Subject has an allergy to contrast medium that cannot be pretreated.
• Episode of acute limb ischemia within past 30 days.
• Subject has systemic infection with positive blood cultures/ bacteremia within one week.
• Subject has a hypercoagulable disorder
• Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
• Myocardial infarction within 30 days prior to enrollment.
• History of stroke or TIA within 90 days prior to enrollment.

Sponsors & Collaborators

• Cagent Vascular LLC: lead

Study Sites (6)

Medical University of Graz

Graz, A-8036, Austria

Location

Klinikum Hochsauerland GmbH

Arnsberg, 59759, Germany

Location

Krankenhaus Buchholz

Buchholz, 21244, Germany

Location

Imland Klinik Rendsburg

Rendsburg, 24768, Germany

Location

Auckland City Hospital

Auckland, Grafton, 1023, New Zealand

Location

Polsko-Amerykańskie Kliniki Serca PAKS

Chrzanów, 32-050, Poland

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: October 3, 2018
• Study Start: December 17, 2019
• Primary Completion: April 11, 2020
• Study Completion: October 23, 2020
• Last Updated: January 28, 2021

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); AU (1); NZ (1); PL (1)