The Indigo System in Acute Lower Limb Malperfusion (INDIAN)

Azienda Ospedaliera Universitaria Senese

Status: Unknown

Conditions: Acute Ischemia of Lower Limb

Treatments: Device: "Indigo" Mechanical Thrombectomy System

Study type: Interventional

Funder types: Other

Identifiers

NCT03386370

Indian001

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Treatment by "Indigo" mechanical thrombectomy system

Other group

Description:

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

Treatment:

Device: "Indigo" Mechanical Thrombectomy System