A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System

NCT04144959 | Completed Results FDA Device

• 1 other identifier: CLP 15549
• Study Type: observational
• Target: 119
• Locations: 3 countries
• Sites: 17

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).

Conditions

Lower Extremity Acute Limb Ischemia; LE ALI

Outcome Measures

Primary Outcomes (1)

• Target Limb Salvage Rate

  Proportion of participants who did not have a major amputation (above the level of the tarsometatarsal joint)

  1-Month Post Procedure

Secondary Outcomes (8)

• Technical Success

  Immediate Post Procedure

• Modified Society for Vascular Surgery Runoff Score

  Pre Procedure and immediately Post Procedure

• Improvement of Rutherford Classification

  Up to discharge or 7 days, whichever occurred first

• Vessel Patency

  1-Month Post-Procedure

• Target Limb Salvage Rate

  12-Months Post Procedure

Study Arms (1)

Patients with lower extremity acute limb ischemia

Device: Indigo Aspiration System

Interventions

Indigo Aspiration System DEVICE

Indigo Aspiration System

Patients with lower extremity acute limb ischemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that present with LE ALI who are eligible for mechanical thrombectomy using the Indigao Aspiration System

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (17)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

Manatee Memorial Hospital

Bradenton, Florida, 34208, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

University of Maryland

Baltimore, Maryland, 20742, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Tisch Hospital NYU Langone Health

New York, New York, 10016, United States

Location

NC Heart and Vascular Research

Cary, North Carolina, 27607, United States

Location

Sanger Heart & Vascular Institute

Charlotte, North Carolina, 28203, United States

Location

Trihealth Good Samaritan Hospital of Cincinnati

Cincinnati, Ohio, 45220, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Holston Valley Medical

Kingsport, Tennessee, 37660, United States

Location

Baylor College of Medicine (St. Luke's Medical Center)

Houston, Texas, 77030, United States

Location

Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States

Location

Klinikum rechts der Isar

München, Germany

Location

St. Franziskus-Hospital - Münster

Münster, Germany

Location

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Spain

Location

Related Publications (1)

• Maldonado TS, Powell A, Wendorff H, Rowse J, Nagarsheth KH, Dexter DJ, Dietzek AM, Muck PE, Arko FR, Chung J; STRIDE study group. Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia. J Vasc Surg. 2024 Mar;79(3):584-592.e5. doi: 10.1016/j.jvs.2023.10.062. Epub 2023 Nov 4.

  PMID: 37931885 DERIVED

Results Point of Contact

• Title: Erin Archard, Senior Director of Clinical Research, Vascular
• Organization: Penumbra, Inc.

earchard@penumbrainc.com

+1 802 377 9715

Study Officials

• Thomas Maldonado, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 30, 2019
• Study Start: December 17, 2019
• Primary Completion: January 2, 2023
• Study Completion: October 20, 2023
• Last Updated: June 27, 2025
• Results First Posted: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); US (14); DE (2)