PRELUDE: PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the Serranator DevicE

Sponsor
Cagent Vascular LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03001700
Collaborator
(none)
25
Enrollment
4
Locations
1
Arm
10.9
Actual Duration (Months)
6.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess preliminary safety and efficacy of the Serranator™ Alto PTA Serration Balloon Catheter in subjects with atherosclerotic peripheral artery disease of the superficial femoral and popliteal arteries.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Serranator™ Alto PTA Serration Balloon Catheter
N/A

Detailed Description

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 :
Feb 1, 2017
Actual Primary Completion Date :
May 31, 2017
Actual Study Completion Date :
Dec 31, 2017

Arms and Interventions

ArmIntervention/Treatment
Experimental: Treatment

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.

Outcome Measures

Primary Outcome Measures

  1. 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. [Through Study Completion, approximately 6 months]

Secondary Outcome Measures

  1. 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. [Through Study Completion, approximately 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 Inclusion Criteria:
  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.

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).

  1. Subject is pregnant or breastfeeding.

  2. 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.

  3. 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.

  4. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.

  5. Known allergies to both antiplatelet agents, aspirin, or heparin.

  6. History of neutropenia, coagulopathy, or thrombocytopenia that was unexplained or is considered to be at risk for reoccurrence.

  7. Platelet count less than 80,000/μL,

  8. Subject requires general anesthesia for the procedure.

  9. Subject requires dialysis.

Angiographic Exclusion Criteria:
  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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Medizinische Universtität GrazGrazAustriaA-8036
2Auckland City HospitalAucklandGraftonNew Zealand1023
3Polsko-Amerykańskie Kliniki Serca PAKS Małopolskie Centrum Sercowo NaczynioweChrzanowPoland32-050
4Szpital Uniwersytecki w Krakowie Pracownia Angiografii Oddział AngiologiiKrakowPoland31-066

Sponsors and Collaborators

  • Cagent Vascular LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cagent Vascular LLC
ClinicalTrials.gov Identifier:
NCT03001700
Other Study ID Numbers:
  • CSP-0109
First Posted:
Dec 23, 2016
Last Update Posted:
Apr 24, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 24, 2018