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NCT02786173 Clinical Trial

Peripheral Registry of Endovascular Clinical Outcomes "The PRIME Registry"

Peripheral Arterial Disease Clinical Trial

— PRIME  

Official title:
Peripheral Registry of Endovascular Clinical Outcomes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02786173
Other study ID # PRIME
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2013
Est. completion date November 5, 2021

Study information
Verified date March 2022
Source Metro Health, Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The PRIME Registry is a multi-center, observational study designed to evaluate immediate and long-term outcomes (36 months) of endovascular revascularization in patients with critical limb ischemia (CLI) and advanced peripheral artery disease (PAD).

Description:

The Peripheral RegIstry of Endovascular Clinical OutcoMEs (PRIME Registry) represents the collaborative effort among seven centers across the US with the goal of reaching 10 sites globally. PRIME explores all aspects of advanced peripheral arterial disease (PAD) and critical limb ischemia (CLI) care including the collection of comprehensive clinical, diagnostic, procedural, and follow-up data for three years following an index endovascular procedure. Data collection activities began in January of 2013 with the goal of collecting data on 1500 subjects. Analysis of this multi-site registry will produce generalizable findings that describe the clinical epidemiology and management practices of advanced PAD and CLI patients.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date November 5, 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients who are to receive or have received lower extremity endovascular intervention - Rutherford III-VI Classification - Ability to provide informed consent within 30 day prior to 60 days post index endovascular intervention. - Ability to follow up at enrollment site. Exclusion Criteria: - Inability or unwillingness to consent for participation in the registry.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States The Hospitals of Providence El Paso Texas
United States Orlando Health Orlando Florida
United States Rex Healthcare Raleigh North Carolina
United States Cox Health Springfield Missouri
United States Prairie Heart Springfield Illinois
United States Metro Health Hospital Wyoming Michigan

Sponsors (4)
Lead Sponsor Collaborator
Metro Health, Michigan Boston Scientific Corporation, C. R. Bard, Cardiovascular Systems Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Amputation free survival rates At 36 month follow-up visit
Secondary Access site and procedural complications At 36 month follow-up visit
Secondary Target lesion revascularization At 36 month follow-up visit
Secondary Target vessel revascularization At 36 month follow-up visit
Secondary Procedural success At 36 month follow-up visit
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