The Indigo System in Acute Lower Limb Malperfusion

NCT03386370 | Unknown FDA Device

• 1 other identifier: Indian001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemia of Lower Limb

Keywords

Acute ischemia; Lower Limb

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical success at 1 month follow-up.

  1 month

• Safety Rate at discharge: Serious adverse event.

  1 month

• Primary Patency

  1 month

Study Arms (1)

Treatment by "Indigo" mechanical thrombectomy system

OTHER

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

Device: "Indigo" Mechanical Thrombectomy System

Interventions

"Indigo" Mechanical Thrombectomy System DEVICE

Removal of acute clot (\< 14 days) from the artery causing lower limb ischemia, using the "Indigo" System by Penumbra

Treatment by "Indigo" mechanical thrombectomy system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Senese: lead

Study Sites (1)

Vascular Surgery, University of Siena

Siena, 53100, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 25644826 BACKGROUND

Central Study Contacts

Gianmarco de Donato, MD

CONTACT

+390577585123; dedonato@unisi.it

Carlo Setacci, MD

CONTACT

+390577233443; setacci@unisi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University of Siena

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 29, 2017
• Study Start: September 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: May 1, 2019
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

IT (1)