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

NCT03001700 | Completed FDA Device

• 1 other identifier: CSP-0109
• Study Type: interventional
• Target: 25
• Locations: 3 countries
• Sites: 4

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects will be treated with the Serranator™ Alto PTA Serration Balloon Catheter device

Device: Serranator™ Alto PTA Serration Balloon Catheter

Interventions

Serranator™ Alto PTA Serration Balloon Catheter DEVICE

The Serranator™ is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.

Treatment

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 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.
• Resting ABI -\< 0.9.
• Subject is eligible for standard surgical repair in target limb if necessary.
• Subject has Rutherford Clinical Category 2,3, or 4
• Estimated life expectancy \> 1 year.
• Lesion(s) located within the SFA and or popliteal arteries.
• Target lesion(s) has stenosis \>70% by visual assessment.
• Reference vessel diameter is between 4.0mm and 6.0mm, inclusive.
• 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.
• De-novo, or non-stented re-stenotic lesions
• At least one below the knee artery patent to the ankle.
• 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.

You may not qualify if:

• Rutherford Clinical Category 1, 5 or 6.
• Previously implanted ipsilateral femoral or popliteal stent.
• 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 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.
• 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 (4)

Medizinische Universtität Graz

Graz, A-8036, Austria

Location

Auckland City Hospital

Auckland, Grafton, 1023, New Zealand

Location

Polsko-Amerykańskie Kliniki Serca PAKS Małopolskie Centrum Sercowo Naczyniowe

Chrzanów, 32-050, Poland

Location

Szpital Uniwersytecki w Krakowie Pracownia Angiografii Oddział Angiologii

Krakow, 31-066, Poland

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

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: December 16, 2016
• First Posted: December 23, 2016
• Study Start: February 1, 2017
• Primary Completion: May 31, 2017
• Study Completion: December 31, 2017
• Last Updated: April 24, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); PL (2); NZ (1)