Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

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).

Official Title

CHEETAH: A Prospective, Multicenter Study to Evaluate the Safety and Performance of the CAT RX Aspiration Catheter in Patients With a High Thrombus Burden Acute Coronary Vessel Occlusion

Keywords

Coronary Vessel Occlusion Thrombosis Indigo Aspiration System

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • UCSD Medical Center accepting new patients
    San Diego California 92103 United States
  • St. Joseph Hospital - Orange accepting new patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Penumbra Inc.
ID
NCT03957473
Study Type
Observational
Last Updated