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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06747117




Registration number
NCT06747117
Ethics application status
Date submitted
18/12/2024
Date registered
24/12/2024
Date last updated
16/07/2025

Titles & IDs
Public title
A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)
Scientific title
STRIDE II: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System II
Secondary ID [1] 0 0
CLP 30000
Universal Trial Number (UTN)
Trial acronym
STRIDE II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower Extremity Acute Limb Ischemia 0 0
LE ALI 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Indigo Aspiration System

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


Treatment: Devices: Indigo Aspiration System
Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Target Limb Salvage Rate
Timepoint [1] 0 0
30 Days Post-Procedure
Secondary outcome [1] 0 0
Technical Success
Timepoint [1] 0 0
Immediate Post Procedure
Secondary outcome [2] 0 0
Primary Patency at 30 Days
Timepoint [2] 0 0
30 Days Post-Procedure
Secondary outcome [3] 0 0
Rates of Device-related Major Bleeding
Timepoint [3] 0 0
Procedure, 30 Days, and 180 Days Post-Procedure
Secondary outcome [4] 0 0
Rates of Device-related Distal Embolization
Timepoint [4] 0 0
During Procedure
Secondary outcome [5] 0 0
Rates of Device-related Serious Adverse Events (SAE)
Timepoint [5] 0 0
Procedure, 30 Days, and 180 Days Post-Procedure
Secondary outcome [6] 0 0
Mortality
Timepoint [6] 0 0
30 Days and 180 Days Post-Procedure

Eligibility
Key inclusion criteria
* Age =18 years
* Patients with a confirmed diagnosis of lower limb arterial occlusion located in the common iliac or below, with a minimum of 2 cm of proximal patency in the common iliac
* Acute occlusion with symptom duration of 14 days or less at presentation
* ALI Rutherford Category I, IIa or IIb
* First-line treatment with the Indigo Aspiration System using Computer Assisted Vacuum Thrombectomy (CAVT) aspiration tubing
* Informed consent is obtained from either patient or legally authorized representative (LAR) per Institutional Review Board/Ethics Committee requirements
* Previously enrolled patients presenting with a new acute occlusion in the contralateral limb meeting all eligibility criteria may be re-enrolled if the new acute occlusion is greater than 30 days from the initial index procedure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Life expectancy <1 year
* Target vessel size <2 mm
* Target thrombus is in the aorta or isolated profunda artery
* Prior major amputation (proximal to the tarsometatarsal joint) in the target limb
* Prior minor amputation in the target limb within the past 6 months that is not completely healed or cannot bear weight
* LE ALI secondary to dissection, vasculitis, or target vessel trauma, including iatrogenic etiology from treatment of a proximal location in the target limb
* Target thrombus in a saphenous vein bypass graft
* Treatment of the index event with thrombolytics or any other endovascular or open surgical method prior to enrollment
* Pregnancy
* Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated
* Other medical, behavioral, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
* Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/05/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2029
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Delaware
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Penumbra Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel Clair, MD
Address 0 0
Vanderbilt University Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marina Mello
Address 0 0
Country 0 0
Phone 0 0
+14078108634
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06747117