Clinical trial NCT02786173: Peripheral Registry of Endovascular Clinical Outcomes "The PRIME Registry"
Official title: Peripheral Registry of Endovascular Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Peripheral Vascular Disease
Critical Limb Ischemia
Keywords: PRIME
PAD
PVD
Observational
CLI
PRIME Registry
Lead sponsor: Metro Health, Michigan
Sponsor class: OTHER
Collaborators: name: C. R. Bard
name: Abbott Medical Devices
name: Boston Scientific Corporation
First posted: 2016-05-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are to receive or have received lower extremity endovascular treatment for peripheral artery disease.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Amputation free survival rates
timeFrame: At 36 month follow-up visit
Secondary outcomes:
measure: Access site and procedural complications
timeFrame: At 36 month follow-up visit
measure: Target lesion revascularization
timeFrame: At 36 month follow-up visit
measure: Target vessel revascularization
timeFrame: At 36 month follow-up visit
measure: Procedural success
timeFrame: At 36 month follow-up visit
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Springfield
country: United States
facility: Prairie Heart
state: Illinois
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Springfield
country: United States
facility: Cox Health
state: Missouri
city: Raleigh
country: United States
facility: Rex Healthcare
state: North Carolina
city: El Paso
country: United States
facility: The Hospitals of Providence
state: Texas
Study officials:
References: