A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Penumbra Inc.
Study ID
NCT06747117
Status
Recruiting
Apply to this trial

Conditions

  • LE ALI
  • Lower Extremity Acute Limb Ischemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Indigo Aspiration System — DEVICE
    Mechanical aspiration thrombectomy with the Indigo Aspiration System.

Study Details

The primary objective of this study is to collect and evaluate clinical evidence supporting the safety and performance of the Indigo™ Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).

Key Dates

Start date
May 18, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Patients with lower extremity acute limb ischemia
    Device: Indigo Aspiration System

Primary Outcome Measure

Target Limb Salvage Rate [ Time Frame: 30 Days Post-Procedure ]

Central Contacts

Locations (31)

FacilityCityStateZIPSite coordinators
HonorHealth Scottsdale Osborn Medical CenterScottsdaleArizona85251-
Sharp Memorial HospitalSan DiegoCalifornia92123-
Community Memorial HospitalVenturaCalifornia93003-
University of Colorado HospitalAuroraColorado80045-
Yale New Haven HospitalNew HavenConnecticut06520-
Christiana Care Health Services, Inc.NewarkDelaware19713-
Manatee Memorial HospitalBradentonFlorida34208-
University of Florida Shands HospitalGainesvilleFlorida32608-
Radiology and Imaging SpecialistsLakelandFlorida33805-
Baptist Hospital of Miami, Miami Cardiac and Vascular InstituteMiamiFlorida33176-
Tampa General HospitalTampaFlorida33606-
Emory University HospitalAtlantaGeorgia30322-
OSF Saint Francis Medical CenterPeoriaIllinois61637-
Community HospitalMunsterIndiana46321-
University of KentuckyLexingtonKentucky40536-
University of MarylandBaltimoreMaryland21201-
UMass Memorial Medical CenterWorcesterMassachusetts01655-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03766-
Mount Sinai HospitalNew YorkNew York10029-
NYU Langone HealthNew YorkNew York10016-
Sanger Heart & Vascular InstituteConcordNorth Carolina28204-
NC Heart and Vascular Research, LLCRaleighNorth Carolina27607-
TriHealth Good Samaritan HospitalCincinnatiOhio45220-
Cleveland ClinicClevelandOhio44195-
Prisma Health Greenville Memorial HospitalGreenvilleSouth Carolina29605-
Lexington Medical CenterWest ColumbiaSouth Carolina29169-
Jackson-Madison County General HospitalJacksonTennessee38301-
William P. Clements Jr. University HospitalDallasTexas75235-
Baylor St. Luke's Medical CenterHoustonTexas77030-
Baylor Scott & White The Heart Hospital - PlanoPlanoTexas75093-
The Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Scottsdale, AZ

By research site
HonorHealth Scottsdale Osborn Medical Center· Scottsdale, AZSharp Memorial Hospital· San Diego, CACommunity Memorial Hospital· Ventura, CAUniversity of Colorado Hospital· Aurora, COYale New Haven Hospital· New Haven, CTChristiana Care Health Services, Inc.· Newark, DE

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