NCT02786173

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 30, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2021

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2022

Enrollment Period

7.9 years

First QC Date

May 17, 2016

Last Update Submit

March 9, 2023

Conditions

Peripheral Arterial DiseasePeripheral Vascular DiseaseCritical Limb Ischemia

Keywords

PRIMEPADPVDObservationalCLIPRIME Registry

Outcome Measures

Primary Outcomes (1)

  • Amputation free survival rates

    At 36 month follow-up visit

Secondary Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who are to receive or have received lower extremity endovascular treatment for peripheral artery disease.

You may qualify if:

  • 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.

You may not qualify if:

  • Inability or unwillingness to consent for participation in the registry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Orlando Health

Orlando, Florida, 32806, United States

Location

Prairie Heart

Springfield, Illinois, 62701, United States

Location

Metro Health Hospital

Wyoming, Michigan, 49519, United States

Location

Cox Health

Springfield, Missouri, 65807, United States

Location

Rex Healthcare

Raleigh, North Carolina, 27607, United States

Location

The Hospitals of Providence

El Paso, Texas, 79902, United States

Location

MeSH Terms

Conditions

Peripheral Arterial DiseasePeripheral Vascular DiseasesChronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 30, 2016

Study Start

January 1, 2013

Primary Completion

December 1, 2020

Study Completion

November 5, 2021

Last Updated

March 13, 2023

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(6)