A Study of Patients With Lower Extremity Acute Limb Ische... | NCT04144959

Label	Type	Description	Intervention Names
Patients with lower extremity acute limb ischemia			Device: Indigo Aspiration System

Name	Type	Description	Arm Group Labels	Other Names
Indigo Aspiration System	Device	Indigo Aspiration System	Patients with lower extremity acute limb ischemia

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Technical Success	Defined as TIMI 2/3 flow rate TIMI flow grade: Grade 0 No perfusion Grade 1 Perfusion past initial occlusion but no distal branch filling. Grade 2 Perfusion with incomplete or slow distal branch filling. Grade 3 Full perfusion with filling of all distal branches.	Immediate Post Procedure

Name	Affiliation	Role
Thomas Maldonado, MD	NYU Langone Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University Medical Center		Stanford	California	94305	United States
Danbury Hospital

PubMed Identifier	Type	Citation	Retractions
41177276	Derived	Maldonado TS, Powell A, Wendorff H, Rowse J, Nagarsheth KH, Dexter DJ, Dietzek AM, Muck PE, Arko FR, Chung J; STRIDE study group. STRIDE study post hoc analysis shows first-line mechanical aspiration thrombectomy for either in-stent or in-graft versus native vessel thrombosis in lower extremity acute limb ischemia yields similar outcomes. J Vasc Surg. 2026 Mar;83(3):839-847.e1. doi: 10.1016/j.jvs.2025.10.038. Epub 2025 Oct 31.
38914349

ID	Title	Description
FG000	Patients With Lower Extremity Acute Limb Ischemia	Indigo Aspiration System: Indigo Aspiration System

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 20, 2021	Feb 26, 2025

ID	Title	Description
BG000	Patients With Lower Extremity Acute Limb Ischemia	Indigo Aspiration System: Indigo Aspiration System

Units	Counts
Participants	BG000119

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Target Limb Salvage Rate

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

The analysis population (ITT) contains 111 evaluable participants.

Posted

Count of Participants

Participants

1-Month Post Procedure

ID	Title	Description
OG000	Patients With Lower Extremity Acute Limb Ischemia	Indigo Aspiration System: Indigo Aspiration System

Units	Counts
Participants	OG000111

Title

Denominators

Categories

Title	Measurements
	OG000109

Secondary

Technical Success

Defined as TIMI 2/3 flow rate

TIMI flow grade:

Grade 0 No perfusion Grade 1 Perfusion past initial occlusion but no distal branch filling. Grade 2 Perfusion with incomplete or slow distal branch filling. Grade 3 Full perfusion with filling of all distal branches.

The analysis population (ITT) contains 109 evaluable participants.

Posted

Count of Participants

Participants

Immediate Post Procedure

ID	Title	Description
OG000	Patients With Lower Extremity Acute Limb Ischemia	Indigo Aspiration System: Indigo Aspiration System

Units	Counts
Participants	OG000

Secondary

Modified Society for Vascular Surgery Runoff Score

Endpoint is change in modified SVS Runoff Score at post-procedure

Modified SVS runoff score ranges from 1-19, with a higher score indicating more severe disease

The analysis population (ITT) contains 106 evaluable participants.

Posted

Mean

Standard Deviation

Change in Modified SVS runoff score

Pre Procedure and immediately Post Procedure

ID	Title	Description
OG000	Patients With Lower Extremity Acute Limb Ischemia	Indigo Aspiration System: Indigo Aspiration System

Units	Counts
Participants	OG000

Secondary

Improvement of Rutherford Classification

Improvement of one or more as compared to pre-procedure

Rutherford classification:

I.Viable Not immediately threatened

IIa.Threatened Marginally Salvageable if promptly treated

IIb. Threatened Immediately Salvageable with immediate revascularization

III. Irreversible

The analysis population (ITT) contains 96 evaluable participants.

Posted

Count of Participants

Participants

Up to discharge or 7 days, whichever occurred first

ID	Title	Description
OG000	Patients With Lower Extremity Acute Limb Ischemia	Indigo Aspiration System: Indigo Aspiration System

Units	Counts
Participants	OG000

Secondary

Vessel Patency

Patency is defined as a target lesion without a hemodynamically significant stenosis /reocclusion on duplex ultrasound (>50 %, ) and without target lesion reintervention (TLR ).

The analysis population (ITT) contains 113 evaluable participants

Posted

Count of Participants

Participants

1-Month Post-Procedure

ID	Title	Description
OG000	Patients With Lower Extremity Acute Limb Ischemia	Indigo Aspiration System: Indigo Aspiration System

Units	Counts
Participants	OG000113

Secondary

Target Limb Salvage Rate

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

The analysis population (ITT) contains 81 evaluable participants.

Posted

Count of Participants

Participants

12-Months Post Procedure

ID	Title	Description
OG000	Patients With Lower Extremity Acute Limb Ischemia	Indigo Aspiration System: Indigo Aspiration System

Units	Counts
Participants	OG00081

Secondary

Rates of Device Related Serious Adverse Events (SAEs)

A SAE is an event that led to death, led to a serious deterioration in the health of the patient that resulted in life-threatening illness or injury, resulted in chronic disease, resulted in permanent impairment of a body structure or a body function, required in-patient hospitalization or prolongation of existing hospitalization, resulted in medical or surgical intervention to arrest permanent impairment to body structure or a body function, led to fetal distress, fetal death or a congenital abnormality or birth defect

The analysis population (ITT) contains 119 evaluable participants.

Posted

Count of Participants

Participants

Up until study completion, at approximately 12-Months

ID	Title	Description
OG000	Patients With Lower Extremity Acute Limb Ischemia	Indigo Aspiration System: Indigo Aspiration System

Units	Counts
Participants	OG000

Secondary

Major Bleeding Peri-procedure

Fatal or leading to a drop in hemoglobin of ≥5 g /dl, or significant hypotension with the need for inotropes, or requiring surgery (other than vascular site repair ), or symptomatic intracranial hemorrhage (ICH ), or requiring transfusion of two or three units of red blood cells or equivalent whole blood

Posted

Count of Participants

Participants

within 2 days of procedure

ID	Title	Description
OG000	Patients With Lower Extremity Acute Limb Ischemia	Indigo Aspiration System: Indigo Aspiration System

Units	Counts
Participants	OG000119

Secondary

Mortality

Death due to any cause

The analysis population contains all participants who were enrolled. All deaths within 365 days are included.

Posted

Count of Participants

Participants

12-Months

ID	Title	Description
OG000	Patients With Lower Extremity Acute Limb Ischemia	Indigo Aspiration System: Indigo Aspiration System

Units	Counts
Participants	OG000119

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Coagulopathy	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Acute myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG0005 events5 affected119 at risk
Cardiac arrest	Cardiac disorders	Non-systematic Assessment	EG0003 events3 affected119 at risk
Cardiac failure	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Cardiac failure acute	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Cardiac failure congestive	Cardiac disorders	Non-systematic Assessment	EG0003 events3 affected119 at risk
Cardiogenic shock	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Ventricular tachycardia	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Colitis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Rectal haemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Small intestinal obstruction	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Amputation stump pain	General disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Death	General disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Impaired healing	General disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Oedema peripheral	General disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Pain	General disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Vascular stent occlusion	General disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Vascular stent stenosis	General disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Vascular stent thrombosis	General disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Cholecystitis acute	Hepatobiliary disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
COVID-19	Infections and infestations	Non-systematic Assessment	EG0003 events3 affected119 at risk
COVID-19 pneumonia	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected119 at risk
Cellulitis	Infections and infestations	Non-systematic Assessment	EG0003 events3 affected119 at risk
Cystitis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected119 at risk
Diabetic foot infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected119 at risk
Endocarditis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected119 at risk
Gangrene	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected119 at risk
Localised infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected119 at risk
Osteomyelitis	Infections and infestations	Non-systematic Assessment	EG0004 events3 affected119 at risk
Postoperative wound infection	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected119 at risk
pyelonephritis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected119 at risk
Sepsis	Infections and infestations	Non-systematic Assessment	EG0004 events4 affected119 at risk
Septic shock	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected119 at risk
Skin graft infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected119 at risk
Staphylococcal infection	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected119 at risk
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG0006 events4 affected119 at risk
Vascular access site infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected119 at risk
Vascular graft infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected119 at risk
Wound infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected119 at risk
Wound infection staphylococcal	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected119 at risk
Ankle fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected119 at risk
Arterial bypass occlusion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected119 at risk
Arterial bypass stenosis	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected119 at risk
Incision site impaired healing	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected119 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected119 at risk
Peripheral artery restenosis	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected119 at risk
Post procedural complication	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected119 at risk
Postoperative wound infection	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected119 at risk
Rib fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected119 at risk
Vascular access site haematoma	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected119 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events1 affected119 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0004 events4 affected119 at risk
Acute respiratory failure	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Hyperglycaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Malnutrition	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0004 events4 affected119 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events1 affected119 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0003 events3 affected119 at risk
Plantar facial fibromatosis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Cutaneous T-cell lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 events1 affected119 at risk
Lung carcinoma cell type unspecified stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 events1 affected119 at risk
Cerebrovascular accident	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Drug withdrawal convulsions	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Embolic stroke	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Generalised tonic clonic seizure	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Ischaemic stroke	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Metabolic encephalopathy	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Multiple sclerosis relapse	Nervous system disorders	Non-systematic Assessment	EG0002 events1 affected119 at risk
Seizure	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Syncope	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Transient ischaemic attack	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Delirium	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Mental status change	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Acute kidney injury	Renal and urinary disorders	Non-systematic Assessment	EG0003 events3 affected119 at risk
Calculus bladder	Renal and urinary disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Hydroponephrosis	Renal and urinary disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Nephrolithiasis	Renal and urinary disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Renal failure	Renal and urinary disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 events3 affected119 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Cellulitis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Hip arthroplasty	Surgical and medical procedures	Non-systematic Assessment	EG0001 events1 affected119 at risk
Toe amputation	Surgical and medical procedures	Non-systematic Assessment	EG0001 events1 affected119 at risk
Aortic dissection	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Arterial bypass stenosis	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Deep vein thrombosis	Vascular disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Haematoma	Vascular disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Haemorrhage	Vascular disorders	Non-systematic Assessment	EG00016 events16 affected119 at risk
Hypertensive urgency	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Orthostatic hypotension	Vascular disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Peripheral artery occlusion	Vascular disorders	Non-systematic Assessment	EG0008 events6 affected119 at risk
Peripheral artery stenosis	Vascular disorders	Non-systematic Assessment	EG0003 events3 affected119 at risk
Peripheral artery thrombosis	Vascular disorders	Non-systematic Assessment	EG0007 events6 affected119 at risk
Peripheral embolism	Vascular disorders	Non-systematic Assessment	EG0005 events4 affected119 at risk
Peripheral ischaemia	Vascular disorders	Non-systematic Assessment	EG00018 events16 affected119 at risk
Vascular dissection	Vascular disorders	Non-systematic Assessment	EG0002 events2 affected119 at risk
Vascular pseudoaneurysm	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk
Vascular stent occlusion	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected119 at risk