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The Indigo System in Acute Lower Limb Malperfusion (INDIAN)

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ClinicalTrials.gov Identifier: NCT03386370
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Carlo Setacci, Gianmarco de Donato, Azienda Ospedaliera Universitaria Senese

Brief Summary:
To evaluate, in a controlled setting, the early safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (San Francisco, California), and to define optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions.

Condition or disease Intervention/treatment Phase
Acute Ischemia of Lower Limb Device: "Indigo" Mechanical Thrombectomy System Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Indian Registry (The INDigo System in Acute Lower Limb malperfusioN)
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Treatment by "Indigo" mechanical thrombectomy system
Acute or Chronic clot: if chronic (> 14 days) no intervention given via Indigo
Device: "Indigo" Mechanical Thrombectomy System
Removal of acute clot (< 14 days) from the artery causing lower limb ischemia, using the "Indigo" System by Penumbra



Primary Outcome Measures :
  1. Technical success of the thromboaspiration with the Indigo system. [ Time Frame: At intra-procedural completion angiography ]
    The primary endpoint of the study is the technical success of the thromboaspiration with the Indigo system. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications both before and after use of the device.


Secondary Outcome Measures :
  1. Clinical success at 1 month follow-up. [ Time Frame: 1 month ]
    Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.

  2. Safety Rate at discharge: Serious adverse event. [ Time Frame: 1 month ]
    Safety rate at discharge, defined as absence of any serious adverse events (SAE). A SAE is defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability.

  3. Primary Patency [ Time Frame: 1 month ]
    Primary patency at 1 month. Primary patency is defined as a target lesion without a hemodynamically significant stenosis/reocclusion on duplex ultrasound (>50%,) and without target lesion reintervention (TLR) within 1 month.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patients will be selected based on the investigator's assessment and evaluation of the underlying disease.

The patient's medical condition should be stable, with no underlying medical condition that would prevent them from performing the required testing or from completing the study.

Patients should be geographically stable, willing and able to cooperate in this clinical study, and remain available for mid term follow-up. Patients who do not wish to participate in this study can obtain any other standard commercially available device therapy. Refusal to participate in this study will in no way affect their care at the institution.

Inclusion Criteria

  • Patient presenting with an acute occlusion of lower limb arteries (thrombosis no longer than 14 days)
  • Patient presenting a score from I to IIb following Rutherford classification for acute limb ischemia
  • Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study
  • Patient is >18 years old
  • Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
  • Patient is eligible for treatment with the Indigo System (Penumbra)

Exclusion Criteria

  • Estimated time of intraluminal thrombus > 14 days
  • Patients refusing treatment
  • Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
  • Patients with a history of prior life-threatening contrast medium reaction
  • Life expectancy of less than six months
  • Any patient considered to be hemodynamically unstable at onset of procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386370


Contacts
Contact: Gianmarco de Donato, MD +390577585123 dedonato@unisi.it
Contact: Carlo Setacci, MD +390577233443 setacci@unisi.it

Locations
Italy
Vascular Surgery, University of Siena Recruiting
Siena, Italy, 53100
Contact: Gianmarco de Donato, MD         
Principal Investigator: Carlo Setacci, MD         
Principal Investigator: Gianmarco de Donato, MD         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Senese

Publications:
Responsible Party: Carlo Setacci, Gianmarco de Donato, University of Siena, Azienda Ospedaliera Universitaria Senese
ClinicalTrials.gov Identifier: NCT03386370     History of Changes
Other Study ID Numbers: Indian001
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Carlo Setacci, Gianmarco de Donato, Azienda Ospedaliera Universitaria Senese:
Acute ischemia
Lower Limb

Additional relevant MeSH terms:
Ischemia
Pathologic Processes