The Indigo System in Acute Lower Limb Malperfusion (INDIAN)

Indian Registry (The INDigo System in Acute Lower Limb malperfusioN)

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.

Study Overview

• Status: Unknown
• Conditions: Acute Ischemia of Lower Limb
• Intervention / Treatment: Device: "Indigo" Mechanical Thrombectomy System

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gianmarco de Donato, MD; Phone Number: +390577585123; Email: dedonato@unisi.it
• Study Contact Backup: Name: Carlo Setacci, MD; Phone Number: +390577233443; Email: setacci@unisi.it

Study Locations

• Italy
  • Siena, Italy, 53100
    • Recruiting
    • Vascular Surgery, University of Siena
    • Contact: Gianmarco de Donato, MD
    • Principal Investigator: Carlo Setacci, MD
    • Principal Investigator: Gianmarco de Donato, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At intra-procedural completion angiography

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month
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.	1 month
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.	1 month

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Senese

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: December 28, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 9, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Lower Limb; Acute ischemia
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: Indian001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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