Registry Study to Evaluate the Performance and Safety of Roxwood Medical Catheters in Arteries of Participants With a Stenotic Lesion or Chronic Total Occlusion (CTO)
NCT04059536 · Status: WITHDRAWN · Type: OBSERVATIONAL
Last updated 2021-07-21
Summary
The purpose of this registry study is to gather real world standard of care (SOC) data on the safety and performance on the Roxwood Medical catheter devices in the treatment of stenotic lesions and CTO.
Conditions
- Chronic Total Occlusion
- Atherosclerosis
- Coronary Artery Disease
- Peripheral Artery Disease
Interventions
- DEVICE
-
Roxwood Anchoring Catheters
Anchoring catheters
- DRUG
-
Acetylsalicylic Acid
Oral Tablet
- DRUG
-
Heparin
Intravenous Injection
Sponsors & Collaborators
-
EKOS Corporation
collaborator INDUSTRY -
Boston Scientific Corporation
lead INDUSTRY
Principal Investigators
-
Thomas Davis, MD · Ascension St John
Eligibility
- Min Age
- 25 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-31
- Primary Completion
- 2019-12-01
- Completion
- 2020-03-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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