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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03001700




Registration number
NCT03001700
Ethics application status
Date submitted
16/12/2016
Date registered
23/12/2016

Titles & IDs
Public title
PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the Serranator DevicE
Scientific title
PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the Serranator DevicE: PRELUDE Study
Secondary ID [1] 0 0
CSP-0109
Universal Trial Number (UTN)
Trial acronym
PRELUDE
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Serranator™ Alto PTA Serration Balloon Catheter

Experimental: Treatment - Subjects will be treated with the Serranator™ Alto PTA Serration Balloon Catheter device


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

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Through Study Completion, approximately 6 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Through Study Completion, approximately 6 months

Eligibility
Key inclusion criteria
1. Male or female of >18 years old.
2. Women of child bearing potential must have a negative 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. Resting ABI -< 0.9.
5. Subject is eligible for standard surgical repair in target limb if necessary.
6. Subject has Rutherford Clinical Category 2,3, or 4
7. Estimated life expectancy > 1 year.

Angiographic

1. Lesion(s) located within the SFA and or popliteal arteries.
2. Target lesion(s) has stenosis >70% by visual assessment.
3. Reference vessel diameter is between 4.0mm and 6.0mm, inclusive.
4. One long or multiple serial lesions that are up to 10 cms, (total occlusions up to 6cm) in length that can be covered by a single balloon.
5. De-novo, or non-stented re-stenotic lesions
6. At least one below the knee artery patent to the ankle.
7. Successful treatment of iliac inflow stenosis to the target limb. Stenosis can be treated during the same procedure using standard angioplasty 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, 5 or 6.
2. Previously implanted ipsilateral femoral or popliteal stent.
3. Evidence of aneurysm or acute thrombus in the target vessel.
4. Subjects with previous bypass surgery in lower target extremity.
5. Planned major amputation (above the ankle) of either limb.
6. Subject has significant stenosis or occlusion of inflow tract not successfully treated (>30% residual stenosis and/or significant complication of the procedure).
7. History of any open surgical procedure within the past 30 days.
8. Planned endovascular or vascular surgery procedure within 14 days prior to the ATK procedure, except to treat the inflow vessels on the day of the procedure, or within the next 30 days after the ATK procedure on the target limb.
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.

Angiographic

1. Chronic Total Occlusions (CTO) > 6cm in length
2. Acute Total Occlusions; evidence of acute thrombus formation by angiography
3. Severe calcification of target lesion described as circumferential calcium and >50% of lesion length.
4. Sub-intimal access required
5. Inability to cross the lesion with a guidewire
6. Atherectomy in the target lesion, target artery or for inflow treatment

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
1/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2017
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
New Zealand
State/province [2] 0 0
Grafton
Country [3] 0 0
Poland
State/province [3] 0 0
Chrzanow
Country [4] 0 0
Poland
State/province [4] 0 0
Krakow

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03001700