INDIAN: The Indigo System in Acute Lower Limb Malperfusion

• Sponsor: Azienda Ospedaliera Universitaria Senese (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03386370
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 19.9
• Patients Per Site Per Month: 7.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemia of Lower Limb	Device: "Indigo" Mechanical Thrombectomy System	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• 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: Sep 1, 2017
• Anticipated Primary Completion Date: Mar 1, 2019
• Anticipated Study Completion Date: May 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Technical success of the thromboaspiration with the Indigo system. [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. [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. [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vascular Surgery, University of Siena	Siena		Italy	53100

Sponsors and Collaborators

• Azienda Ospedaliera Universitaria Senese

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Yamada R, Adams J, Guimaraes M, Schönholz 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.

• Responsible Party: Carlo Setacci, Gianmarco de Donato, University of Siena, Azienda Ospedaliera Universitaria Senese
• ClinicalTrials.gov Identifier: NCT03386370
• Other Study ID Numbers: Indian001
• First Posted: Dec 29, 2017
• Last Update Posted: Jan 10, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Keywords provided by Carlo Setacci, Gianmarco de Donato, University of Siena, Azienda Ospedaliera Universitaria Senese: Acute ischemia; Lower Limb
• Additional relevant MeSH terms: Ischemia

Study Results

No Results Posted as of Jan 10, 2019