LE ALI Clinical Trial
— STRIDEOfficial title:
STRIDE: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
| Verified date | January 2024 |
| Source | Penumbra Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 119 |
| Est. completion date | October 20, 2023 |
| Est. primary completion date | January 2, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinikum rechts der Isar | Muenchen | |
| Germany | St. Franziskus-Hospital - Münster | Münster | |
| Spain | Hospital Clínico Universitario de Santiago | Santiago De Compostela | |
| United States | Albany Medical Center | Albany | New York |
| United States | University of Maryland | Baltimore | Maryland |
| United States | Manatee Memorial Hospital | Bradenton | Florida |
| United States | NC Heart and Vascular Research | Cary | North Carolina |
| United States | Sanger Heart & Vascular Institute | Charlotte | North Carolina |
| United States | Good Samaritan Hospital of Cincinnati | Cincinnati | Ohio |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Danbury Hospital | Danbury | Connecticut |
| United States | Baylor College of Medicine (St. Luke's Medical Center) | Houston | Texas |
| United States | Holston Valley Medical | Kingsport | Tennessee |
| United States | Baptist Hospital of Miami | Miami | Florida |
| United States | Tisch Hospital NYU Langone Health | New York | New York |
| United States | Sentara Vascular Specialists | Norfolk | Virginia |
| United States | Stanford University Medical Center | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Penumbra Inc. |
United States, Germany, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Target limb salvage rate | 1-Month Post Procedure | ||
| Secondary | Technical Success | Defined as TIMI 2/3 flow rate TIMI flow grading range 1-3, with higher grading representing better outcome |
Immediate Post Procedure | |
| Secondary | Modified SVS runoff score | Immediate Post Procedure as compared to Baseline Modified SVS runoff score ranges from 0-19, with a higher score indicating more severe disease |
Immediate Post Procedure | |
| Secondary | Improvement of Rutherford classification | Improvement of one or more as compared to pre-procedure Rutherford classification ranges from I-III, with a higher score representing worse outcomes |
Up until study completion, at approximately 12-Months | |
| Secondary | Vessel Patency | 1-Month Post-Procedure | ||
| Secondary | Target limb salvage rate | 12-Months Post Procedure | ||
| Secondary | Rates of device related serious adverse events (SAEs) | Up until study completion, at approximately 12-Months | ||
| Secondary | Major bleeding peri-procedure | During procedure | ||
| Secondary | Mortality | 12-Months |