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Status unknownNCT05161039Updated Jun 9, 2022

Serranator Recoil Study

An interventional study of Serranator and POBA in Peripheral Arterial Disease and Critical Limb Ischemia, sponsored by Cagent Vascular LLC. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-09.

Sponsored by Cagent Vascular LLC · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as defined by post treatment recoil, lumen gain, and dissection will be collected.

Read the detailed description

Multi-center, feasibility study treating up to 20 atherosclerotic lesions in the infrapopliteal arteries. The study will capture angiographic imaging (pre, during, post, and post 15 mins) for all lesions, and a subset (up to 10) of IVUS imaging data (pre, post, and post 15 mins), to compare serration angioplasty vs standard angioplasty and its effects on vessel recoil and final diameter stenosis.

02

Conditions studied

03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's planned enrollment of 20 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Cagent Vascular LLC is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female of >18 years old.
  2. Women of childbearing 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, and has signed the consent form.
  4. Subject has Rutherford Clinical Category 3, 4, 5, or 6.

Angiographic Inclusion Criteria:

  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 infrapopliteal tibial arteries including pedal;
  5. A target lesion may consist of one long or multiple serial lesions that are up to and including 12 cm in length;
  6. If a second lesion is identified in another vessel, the second lesion can also be treated and if treated will be treated with the alternate treatment.

Exclusion criteria

Exclusion Criteria:

  1. Evidence of aneurysm or acute thrombus in the target vessel.
  2. Subject has an allergy to contrast medium that cannot be pretreated.
  3. Subject is pregnant or breastfeeding.

Angiographic Exclusion Criteria:

  1. Acute Total Occlusions; evidence of acute thrombus formation by angiography.
  2. In-stent restenotic lesions.
  3. Inability to cross the lesion with the assigned study device.
  4. Treatment of target lesion with atherectomy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Serranator

    Device: Serranator

  • Other
    POBA

    Device: POBA

Interventions

  • DeviceSerranator

    Serranator® PTA Serration Balloon Catheter manufactured by Cagent Vascular

  • DevicePOBA

    Plain balloon angioplasty device

06

What researchers measure

Primary outcomes

  1. Presence of post treatment recoil

    Obtain preliminary data on post treatment recoil in infrapopliteal arteries utilizing angiographic and IVUS data following serration angioplasty and standard angioplasty.

    Time frame: 15 minutes post procedure

07

Study locations

2 of 2 sites recruiting
  • Stanford University
    Palo Alto, California 94305, United States
    • Venita Chandra, MD · Contact
    Recruiting
  • Klinik für Angiologie, Klinikum Hochsauerland GmbH
    Arnsberg, Germany
    • Stefan Stahlhoff, MD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05161039
Lead sponsor
Cagent Vascular LLC
Responsible party
Sponsor
First posted
Dec 16, 2021
Start date
Nov 15, 2021
Primary completion
Jul 2022 (estimated)
Completion
Jul 2022 (estimated)
Last update
Jun 9, 2022

Study contacts

Robert Giasolli
Contact
rgiasolli@cagentvascular.com
610.688.2006

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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