NCT03957473

Study of the CAT RX Aspiration Catheter When Used in Patients With Large Occlusive Thrombus in Coronary Arteries

Completed Results posted Last updated 10 October 2023

What this trial tests

trial testing Indigo Aspiration System in Coronary Vessel Occlusion in 400 participants. Completed in 2 June 2021.

Timeline

22 August 2019

Primary endpoint
18 January 2021

2 June 2021

Quick facts

Lead sponsor	Penumbra Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	400
Start date	22 August 2019
Primary completion	18 January 2021
Estimated completion	2 June 2021
Sites	25 locations across United States

Drugs / interventions tested

• Indigo Aspiration System

Conditions studied

• Coronary Vessel Occlusion — all drugs for Coronary Vessel Occlusion →

Sponsor

Penumbra Inc. — full company profile →

Who can join

18 and older, any sex, with Coronary Vessel Occlusion. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Composite of: Primary · 30 days

Cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association Class IV heart failure

Group	Value	95% CI
Single Arm	14

Final TIMI Flow Grade Secondary · Procedure

TIMI flow grading range 0-3, with higher grading representing better outcome

Group	Value	95% CI
Single Arm	0
Single Arm	0
Single Arm	10
Single Arm	390

Final TIMI Thrombus Grade Secondary · Procedure

TIMI Thrombus grading range 0-5, with lower grading representing better outcome

Group	Value	95% CI
Single Arm	398
Single Arm	1
Single Arm	1
Single Arm	0

Myocardial Blush Grade Secondary · Procedure

Myocardial blush grading range 0-3, with higher grading representing better outcome

Group	Value	95% CI
Single Arm	0
Single Arm	0
Single Arm	1
Single Arm	399

Distal Embolization Rate Secondary · Procedure

Group	Value	95% CI
Single Arm	3

Stent Thrombosis Secondary · 180 Days

Group	Value	95% CI
Single Arm	9

Stroke Secondary · 30 Days

Group	Value	95% CI
Single Arm	3

Major Bleeding Secondary · 30 Days

Group	Value	95% CI
Single Arm	4

All-Cause Mortality Secondary · 180 Days

Group	Value	95% CI
Single Arm	9

Cardiovascular Death Secondary · 180 Days

Group	Value	95% CI
Single Arm	4

Recurrent MI Secondary · 180 Days

Group	Value	95% CI
Single Arm	10

Cardiogenic Shock Secondary · 180 Days

Group	Value	95% CI
Single Arm	8

Adverse events — posted to ClinicalTrials.gov

Time frame: Procedure through 180 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single Arm

Serious: 144/400 (36%)

Deaths: 10/400

Serious adverse events (66 terms)

Reaction	System	Single Arm
Acute myocardial infarction	Cardiac disorders	—
Cardiac arrest	Cardiac disorders	—
Ischaemic stroke	Nervous system disorders	—
Atrial fibrillation	Cardiac disorders	—
Pneumonia	Infections and infestations	—
Acute kidney injury	Renal and urinary disorders	—
Angina pectoris	Cardiac disorders	—
Angina unstable	Cardiac disorders	—
Chest pain	General disorders	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—
Bradycardia	Cardiac disorders	—
Cardiac failure chronic	Cardiac disorders	—
Vascular stent thrombosis	General disorders	—
Haemorrhage	Vascular disorders	—
Cardiogenic shock	Cardiac disorders	—
Ventricular tachycardia	Cardiac disorders	—
Procedural hypotension	Injury, poisoning and procedural complications	—
Hypotension	Vascular disorders	—
Anaemia	Blood and lymphatic system disorders	—
Ventricular fibrillation	Cardiac disorders	—
COVID-19	Infections and infestations	—
Sepsis	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Vascular access site haemorrhage	Injury, poisoning and procedural complications	—
Renal failure	Renal and urinary disorders	—

Other adverse events (19 terms — click to expand)

Reaction	System	Single Arm
Chest pain	General disorders	—
Vascular access site haemorrhage	Injury, poisoning and procedural complications	—
Angina pectoris	Cardiac disorders	—
Arteriospasm coronary	Cardiac disorders	—
Atrial fibrillation	Cardiac disorders	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—
Vascular access site haemorrhage	Injury, poisoning and procedural complications	—
Haemodynamic instability	Vascular disorders	—
Cardiac failure chronic	Cardiac disorders	—
Coronary artery disease	Cardiac disorders	—
Post procedural cellulitis	Infections and infestations	—
Incision site haemorrhage	Injury, poisoning and procedural complications	—
Dizziness	Nervous system disorders	—
Encephalopathy	Nervous system disorders	—
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	—
Deep vein thrombosis	Vascular disorders	—
Haematoma	Vascular disorders	—
Haemorrhage	Vascular disorders	—
Hypotension	Vascular disorders	—

Most-reported serious reactions: Acute myocardial infarction, Cardiac arrest, Ischaemic stroke, Atrial fibrillation, Pneumonia, Acute kidney injury, Angina pectoris, Angina unstable.

Data from ClinicalTrials.gov NCT03957473 adverse events section.

Sponsor's own description

The objective of this study is to demonstrate the safety and performance of the Indigo Aspiration System using the CAT RX aspiration catheter in a population presenting with acute high thrombus burden coronary vessel occlusion who are referred for Percutaneous Coronary Intervention (PCI).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Sustained Mechanical Aspiration Thrombectomy for High Thrombus Burden Coronary Vessel Occlusion: The Multicenter CHEETAH Study.
   Mathews SJ, Parikh SA, Wu W, Metzger DC, et al · · 2023 · cited 28× · PMID 36802804 · DOI 10.1161/circinterventions.122.012433