A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)
Condition(s) studied
Investigational drug(s) / intervention(s)
Indigo Aspiration System: Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Study summary
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).
Eligibility
Primary outcome measure(s)
- Target Limb Salvage Rate — 30 Days Post-Procedure
Trial sites (45)
| Facility | City | Region | Status |
|---|---|---|---|
| HonorHealth Scottsdale Osborn Medical Center | Scottsdale | Arizona | Recruiting |
| Sharp Memorial Hospital | San Diego | California | Recruiting |
| Community Memorial Hospital | Ventura | California | Recruiting |
| University of Colorado Hospital | Aurora | Colorado | Recruiting |
| Yale New Haven Hospital | New Haven | Connecticut | Recruiting |
| Christiana Care Health Services, Inc. | Newark | Delaware | Recruiting |
| Manatee Memorial Hospital | Bradenton | Florida | Recruiting |
| University of Florida Shands Hospital | Gainesville | Florida | Recruiting |
| Radiology and Imaging Specialists | Lakeland | Florida | Recruiting |
| Baptist Hospital of Miami, Miami Cardiac and Vascular Institute | Miami | Florida | Recruiting |
| Tampa General Hospital | Tampa | Florida | Recruiting |
| Emory University Hospital | Atlanta | Georgia | Recruiting |
| OSF Saint Francis Medical Center | Peoria | Illinois | Withdrawn |
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | Recruiting |
| Community Hospital | Munster | Indiana | Recruiting |
| University of Kentucky | Lexington | Kentucky | Recruiting |
| University of Maryland | Baltimore | Maryland | Recruiting |
| UMass Memorial Medical Center | Worcester | Massachusetts | Recruiting |
| Saint Louis University Hospital | St Louis | Missouri | Recruiting |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | Recruiting |
| NYU Langone Health | New York | New York | Recruiting |
| Mount Sinai Hospital | New York | New York | Recruiting |
| UNC Medical Center Hospital | Chapel Hill | North Carolina | Recruiting |
| Sanger Heart & Vascular Institute | Concord | North Carolina | Recruiting |
| NC Heart and Vascular Research, LLC | Raleigh | North Carolina | Recruiting |
| TriHealth Good Samaritan Hospital | Cincinnati | Ohio | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| Prisma Health Greenville Memorial Hospital | Greenville | South Carolina | Recruiting |
| Lexington Medical Center | West Columbia | South Carolina | Recruiting |
| Jackson-Madison County General Hospital | Jackson | Tennessee | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | Recruiting |
| William P. Clements Jr. University Hospital | Dallas | Texas | Recruiting |
| Baylor St. Luke's Medical Center | Houston | Texas | Recruiting |
| Baylor Scott & White The Heart Hospital - Plano | Plano | Texas | Recruiting |
| The Medical College of Wisconsin | Milwaukee | Wisconsin | Recruiting |
| Flinders Medical Centre | Bedford Park | South Australia | Recruiting |
| Royal North Shore Hospital | Sydney | Australia | Recruiting |
| UFMG Hospital Risoleta Tolentino Neves | Belo Horizonte | Brazil | Recruiting |
| Universitätsklinikum Köln | Cologne | Germany | Recruiting |
| Universitätsklinik Leipzig | Leipzig | Germany | Recruiting |
+ 5 more sites — see the full list on the official registry below.
More Penumbra Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06747117 on ClinicalTrials.gov ↗ ← All trials in the USA