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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03693963




Registration number
NCT03693963
Ethics application status
Date submitted
20/07/2018
Date registered
3/10/2018
Date last updated
28/01/2021

Titles & IDs
Public title
The PRELUDE BTK Study
Scientific title
PRospective Study for the TrEatment of Atherosclerotic Lesions in the Infrapopliteal Arteries Using the Serranator® DevicE: PRELUDE BTK (Below The Knee) Study
Secondary ID [1] 0 0
CSP-0197
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Critical Limb Ischemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Serranator

Other: Single Arm, treated with Serranator - Subjects treated with Serrantor


Treatment: Devices: Serranator
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of MALE and POD (Safety)
Timepoint [1] 0 0
30 days post procedure
Secondary outcome [1] 0 0
Rate of Device Success (Procedural Efficacy)
Timepoint [1] 0 0
Immediately Post Serranator treatment

Eligibility
Key inclusion criteria
1. Male or female of >18 years old.
2. Women of child bearing potential must have a negative urine pregnancy test within 7 days of index procedure.
3. 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.
4. Subject is eligible for standard surgical repair in target limb if necessary.
5. Subject has Rutherford Clinical Category 3, 4 or 5. Enrollment of Rutherford 3 will be limited to no more than 40% of total subjects.
6. Estimated life expectancy > 1 year.

Angiographic

1. Target lesion(s) has stenosis >70% by visual assessment;
2. De-novo, or non-stented re-stenotic lesions;
3. Reference vessel diameter is between 2.5 mm and 3.5 mm, inclusive;
4. Target lesions involve infra-popliteal tibial arteries above the tibio-talar joint;
5. Up to two target lesion(s) may be treated. These target lesions may be located in a single or two infrapopliteal arteries;
6. 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);
7. If more than one critical lesion is identified in two different vessels but only one lesion matches the inclusion criteria, that lesion should be treated as the target lesion and the other non-qualifying lesion in the other vessel may be treated with commercial devices in any manner the investigator decides except by atherectomy;
8. 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;
9. 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;
10. 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;
11. Successful treatment of inflow stenosis (DS>50%), from the iliac to the target lesion. Stenosis can be treated during the same procedure using standard angioplasty, DCB, DES, and/or stenting but use of atherectomy is excluded. The inflow lesion(s) must be treated first, prior to consideration of treatment of the target lesion. Subject can be enrolled if the inflow lesion(s) are treated and results in <30% residual stenosis and no evidence of embolization or significant complications.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Rutherford Clinical Category 1, 2, or 6
2. Evidence of aneurysm or acute thrombus in the target vessel.
3. Subjects with previous bypass surgery in lower target extremity.
4. Planned major amputation (above the ankle) of either limb.
5. Subject has significant stenosis or occlusion of inflow tract not successfully treated (>30% residual stenosis and/or significant complication of the procedure).
6. History of any open surgical procedure within the past 30 days.
7. 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.
8. Planned intervention of occluded or stenotic pedal arteries at the time of the index procedure.
9. Subject has an allergy to contrast medium that cannot be pretreated.
10. Episode of acute limb ischemia within past 30 days.
11. Subject has systemic infection with positive blood cultures/ bacteremia within one week.
12. Subject has a hypercoagulable disorder
13. Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
14. Myocardial infarction within 30 days prior to enrollment.
15. History of stroke or TIA within 90 days prior to enrollment.
16. Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL or >220 umol/L).
17. Subject is pregnant or breastfeeding.
18. Subject is participating in another research study of a device, medication, which could, in the opinion of the investigator, affect the results of this study.
19. Subject has other medical, social or psychological problems that in the opinion of the investigator would preclude them from receiving this treatment and the procedures and or participating in evaluations pre- and post-treatment.
20. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
21. Known allergies to both antiplatelet agents, aspirin, or heparin.
22. History of neutropenia, coagulopathy, or thrombocytopenia that was unexplained or is considered to be at risk for reoccurrence.
23. Platelet count less than 80,000/µL.
24. Subject requires general anesthesia for the procedure.
25. Subject requires dialysis.
26. Subject has heel gangrene and anything worse than WIfI 2.

Angiographic

1. De-novo, or non-stented re-stenotic lesions or Chronic Total Occlusions (CTO) > 12 cm in length.
2. Acute Total Occlusions; evidence of acute thrombus formation by angiography.
3. In-stent restenotic lesions.
4. Inability to cross the lesion with a guidewire.
5. Atherectomy for inflow treatment or planned use in below the knee vessel(s)
6. Intended use of adjunctive primary treatment modalities of target lesion(s) (atherectomy, laser, cutting balloons, DCBs, stents).
7. If two critical lesions are in one vessel but only one lesion qualifies, and the other does not, the subject should not be included in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/10/2020
Sample size
Target
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Germany
State/province [2] 0 0
Arnsberg
Country [3] 0 0
Germany
State/province [3] 0 0
Buchholz
Country [4] 0 0
Germany
State/province [4] 0 0
Rendsburg
Country [5] 0 0
New Zealand
State/province [5] 0 0
Grafton
Country [6] 0 0
Poland
State/province [6] 0 0
Chrzanów

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cagent Vascular LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03693963
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03693963