The Indigo System in Acute Lower Limb Malperfusion

Acute Ischemia of Lower Limb Clinical Trial

— INDIAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03386370
• Other study ID #: Indian001
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: May 2019

Study information

• Verified date: January 2019
• Source: Azienda Ospedaliera Universitaria Senese
• Contact: Gianmarco de Donato, MD
• Phone: +390577585123
• Email: dedonato[@]unisi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemia of Lower Limb
• Ischemia

Intervention

Device:
• "Indigo" Mechanical Thrombectomy System
Removal of acute clot (< 14 days) from the artery causing lower limb ischemia, using the "Indigo" System by Penumbra

Locations

Country	Name	City	State
Italy	Vascular Surgery, University of Siena	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Senese

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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