Peripheral Registry of Endovascular Clinical Outcomes The PRIME Registry

Peripheral Registry of Endovascular Clinical Outcomes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02786173

Acronym

PRIME

Enrollment

1000

Registered

2016-05-30

Start date

2013-01-31

Completion date

2021-11-05

Last updated

2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease

Keywords

PRIME, PAD, PVD, Observational, CLI, PRIME Registry

Brief 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).

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Amputation free survival rates	At 36 month follow-up visit

Secondary

Measure	Time frame
Access site and procedural complications	At 36 month follow-up visit
Target lesion revascularization	At 36 month follow-up visit
Target vessel revascularization	At 36 month follow-up visit
Procedural success	At 36 month follow-up visit

Countries

United States

Outcome results