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

Completed

Conditions studied: Coronary Vessel Occlusion

In brief

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).

Key facts

Study ID

NCT03957473

Run by

Penumbra Inc.

People needed

400

Starts

2019-08-22

Expected to finish

2021-06-02

Last updated by the study team

2023-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient age ≥ 18 years
• Patient presents to treating facility within 12 hours of symptom onset
• High thrombus burden at coronary angiography, defined as TIMI thrombus grade 4 or 5 by physician visual estimate after the guidewire crosses the target lesion
• Frontline treatment with the Indigo® Aspiration System using the CAT RX Aspiration Catheter, prior to standard of care PCI
• Target lesion is located in a native coronary artery
• Informed consent is obtained from either patient or legally authorized representative (LAR)

You may not qualify if…

• New onset of stroke symptoms and NIHSS > 2, prior to index procedure
• Treatment with fibrinolytic therapy for index coronary vessel occlusion
• Life expectancy less than 6 months due to any comorbidities
• 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
• 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 commercially available are not considered investigational studies.
• Patient is pregnant

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States
• St. Joseph Hospital - Orange — Orange, California, United States
• UCSD Medical Center — San Diego, California, United States
• Manatee Memorial Hospital — Bradenton, Florida, United States
• Clearwater Cardiovascular Consultants — Clearwater, Florida, United States
• Largo Medical Center — Largo, Florida, United States
• AdventHealth Tampa (Florida Hospital Tampa) — Tampa, Florida, United States
• Mercy Medical Des Moines — Des Moines, Iowa, United States
• Jewish Hospital — Louisville, Kentucky, United States
• St. John Hospital — Detroit, Michigan, United States
• Metro Health Hospital — Grand Rapids, Michigan, United States
• Metropolitan Heart & Vascular — Coon Rapids, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Missouri Baptist Medical Center — St Louis, Missouri, United States
• Desert Springs Hospital — Las Vegas, Nevada, United States
• University at Buffalo Medical Center — Buffalo, New York, United States
• NYU Langone — New York, New York, United States
• NC Heart & Vascular Research — Raleigh, North Carolina, United States
• Mercy West Hospital — Cincinnati, Ohio, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• Rapid City Regional Hospital — Rapid City, South Dakota, United States
• Wellmont Holston Valley Medical Center — Kingsport, Tennessee, United States
• Turkey Creek Medical Center — Knoxville, Tennessee, United States
• Kingwood Medical Center — Kingwood, Texas, United States
• Sentara Norfolk General — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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