Clinical trial NCT03386370: The Indigo System in Acute Lower Limb Malperfusion
Official title: Indian Registry (The INDigo System in Acute Lower Limb malperfusioN)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Ischemia of Lower Limb
Keywords: Acute ischemia
Lower Limb
Lead sponsor: Azienda Ospedaliera Universitaria Senese
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Technical success of the thromboaspiration with the Indigo system.
timeFrame: At intra-procedural completion angiography
Secondary outcomes:
measure: Clinical success at 1 month follow-up.
timeFrame: 1 month
measure: Safety Rate at discharge: Serious adverse event.
timeFrame: 1 month
measure: Primary Patency
timeFrame: 1 month
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Vascular Surgery, University of Siena
Study officials:
References:
citation: 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.