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Retrospective for Peripheral Arterial Disease (PROWL Trial)
N/A
Recruiting
Led By Sean Lyden, MD
Research Sponsored by SurModics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up peri-procedural (by the end of the index procedure)
Awards & highlights
PROWL Trial Summary
The PROWL registry is an open-label retrospective, multi-center, US study of the Surmodics™ Pounce™ Thrombectomy System for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature.
Eligible Conditions
- Peripheral Arterial Disease
- Acute Limb Ischemia
PROWL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ peri-procedural (by the end of the index procedure)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~peri-procedural (by the end of the index procedure)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of device related Major Adverse Events (MAEs)
Procedural Success
Secondary outcome measures
Adjunctive procedures
Ankle Brachial Index (ABI)
Characterize subject index procedure hospitalization course at discharge
+15 morePROWL Trial Design
1Treatment groups
Experimental Treatment
Group I: RetrospectiveExperimental Treatment1 Intervention
All subjects in whom the Pounce Thrombectomy System was attempted will be included.
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Who is running the clinical trial?
SurModics, Inc.Lead Sponsor
6 Previous Clinical Trials
577 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
494 Patients Enrolled for Peripheral Arterial Disease
Sean Lyden, MDPrincipal InvestigatorThe Cleveland Clinic
8 Previous Clinical Trials
2,403 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
820 Patients Enrolled for Peripheral Arterial Disease
Joseph Campbell, MDPrincipal InvestigatorOhioHealth
1 Previous Clinical Trials
46 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
46 Patients Enrolled for Peripheral Arterial Disease
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