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The Indigo System in Acute Lower Limb Malperfusion (INDIAN)

Primary Purpose

Acute Ischemia of Lower Limb

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
"Indigo" Mechanical Thrombectomy System
Sponsored by
Azienda Ospedaliera Universitaria Senese
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemia of Lower Limb focused on measuring Acute ischemia, Lower Limb

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vascular Surgery, University of SienaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment by "Indigo" mechanical thrombectomy system

Arm Description

Acute or Chronic clot: if chronic (> 14 days) no intervention given via Indigo

Outcomes

Primary Outcome Measures

Technical success of the thromboaspiration with the Indigo system.
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

Clinical success at 1 month follow-up.
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.
Safety Rate at discharge: Serious adverse event.
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.
Primary Patency
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.

Full Information

First Posted
December 18, 2017
Last Updated
January 9, 2019
Sponsor
Azienda Ospedaliera Universitaria Senese
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1. Study Identification

Unique Protocol Identification Number
NCT03386370
Brief Title
The Indigo System in Acute Lower Limb Malperfusion
Acronym
INDIAN
Official Title
Indian Registry (The INDigo System in Acute Lower Limb malperfusioN)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Universitaria Senese

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemia of Lower Limb
Keywords
Acute ischemia, Lower Limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment by "Indigo" mechanical thrombectomy system
Arm Type
Other
Arm Description
Acute or Chronic clot: if chronic (> 14 days) no intervention given via Indigo
Intervention Type
Device
Intervention Name(s)
"Indigo" Mechanical Thrombectomy System
Intervention Description
Removal of acute clot (< 14 days) from the artery causing lower limb ischemia, using the "Indigo" System by Penumbra
Primary Outcome Measure Information:
Title
Technical success of the thromboaspiration with the Indigo system.
Description
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.
Time Frame
At intra-procedural completion angiography
Secondary Outcome Measure Information:
Title
Clinical success at 1 month follow-up.
Description
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.
Time Frame
1 month
Title
Safety Rate at discharge: Serious adverse event.
Description
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.
Time Frame
1 month
Title
Primary Patency
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gianmarco de Donato, MD
Phone
+390577585123
Email
dedonato@unisi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Carlo Setacci, MD
Phone
+390577233443
Email
setacci@unisi.it
Facility Information:
Facility Name
Vascular Surgery, University of Siena
City
Siena
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianmarco de Donato, MD
First Name & Middle Initial & Last Name & Degree
Carlo Setacci, MD
First Name & Middle Initial & Last Name & Degree
Gianmarco de Donato, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25644826
Citation
Yamada R, Adams J, Guimaraes M, Schonholz C. Advantages to Indigo mechanical thrombectomy for ALI: device and technique. J Cardiovasc Surg (Torino). 2015 Jun;56(3):393-400. Epub 2015 Feb 3.
Results Reference
background

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The Indigo System in Acute Lower Limb Malperfusion

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