Clinical trial NCT04144959: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
Official title: STRIDE: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Extremity Acute Limb Ischemia
LE ALI
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-30
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that present with LE ALI who are eligible for mechanical thrombectomy using the Indigao Aspiration System

Brief summary: The primary objective of this study is to collect safety and performance data on the Indigo Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).


Eligibility criteria: Inclusion Criteria:

* Patient age ≥ 18
* Patient presents with acute (≤14 days) occlusion of lower limb artery(ies) (below inguinal ligament)
* Patient with a Rutherford Category IIa or IIb score
* Frontline treatment with Indigo Aspiration System
* Informed consent is obtained from either patient or legally authorized representative (LAR)

Exclusion Criteria:

* Life expectancy \<1 year
* Vessel size \<2 mm
* LE ALI secondary to dissections, vasculitis, and/or target vessel trauma
* Amputation in the ipsilateral limb
* Pregnancy or positive pregnancy test according to site specific standards of care (only required for women of child bearing potential, serum or urine acceptable)
* Absolute contraindication to contrast administration
* Patient is unwilling or unable to comply with protocol follow up schedule and/or based on the Investigator's judgment the patient is not a good study candidate
* Currently participating in an investigational drug or device clinical trial that may confound the study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.

Primary outcomes:
measure: Target limb salvage rate
timeFrame: 1-Month Post Procedure
Secondary outcomes:
measure: Technical Success
timeFrame: Immediate Post Procedure
measure: Modified SVS runoff score
timeFrame: Immediate Post Procedure
measure: Improvement of Rutherford classification
timeFrame: Up until study completion, at approximately 12-Months
measure: Vessel Patency
timeFrame: 1-Month Post-Procedure
measure: Target limb salvage rate
timeFrame: 12-Months Post Procedure
measure: Rates of device related serious adverse events (SAEs)
timeFrame: Up until study completion, at approximately 12-Months
measure: Major bleeding peri-procedure
timeFrame: During procedure
measure: Mortality
timeFrame: 12-Months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Danbury
country: United States
facility: Danbury Hospital
state: Connecticut
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: Tisch Hospital NYU Langone Health
state: New York
city: Cary
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Charlotte
country: United States
facility: Sanger Heart & Vascular Institute
state: North Carolina
city: Cincinnati
country: United States
facility: Good Samaritan Hospital of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Kingsport
country: United States
facility: Holston Valley Medical
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine (St. Luke's Medical Center)
state: Texas
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar
city: Münster
country: Germany
facility: St. Franziskus-Hospital - Münster
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
Study officials:
affiliation: NYU Langone Medical Center
name: Thomas Maldonado, MD
role: PRINCIPAL_INVESTIGATOR
References: