NCT03386370UnknownNot Applicable
Indian Registry (The INDigo System in Acute Lower Limb malperfusioN)
Azienda Ospedaliera Universitaria Senese1 site in 1 country150 target enrollmentStarted: September 1, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Technical success of the thromboaspiration with the Indigo system.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Arms & Interventions
Treatment by "Indigo" mechanical thrombectomy system
Other
Acute or Chronic clot: if chronic (> 14 days) no intervention given via Indigo
Intervention: "Indigo" Mechanical Thrombectomy System (Device)
Outcomes
Primary Outcomes
Technical success of the thromboaspiration with the Indigo system.
Time Frame: 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 Outcomes
- Safety Rate at discharge: Serious adverse event.(1 month)
- Clinical success at 1 month follow-up.(1 month)
- Primary Patency(1 month)
Investigators
Carlo Setacci, Gianmarco de Donato
University of Siena
Azienda Ospedaliera Universitaria Senese
Study Sites (1)
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