Peripheral Arterial Occlusive DiseaseLIBERTYNCT01855412

Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes

An observational study of Peripheral Arterial Occlusive Disease, run by Abbott Medical Devices at 52 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate acute and long term clinical and economic outcomes of endovascular procedures to treat Peripheral Arterial Disease (PAD). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Arterial Occlusive Disease
What is being tested?: PAD endovascular treatments
How many people: 1,204 participants
Where: 52 sitesUnited States
Study dates: May 2013to 11 Apr 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients who have been determined by their physician to require endovascular device treatment for their PAD.

Who may be able to join

Subject's age ≥ 18 years.
Subject presents with a Rutherford classification of 2 to 6.
Subject presents with clinical evidence of PAD requiring endovascular intervention on one or both limbs that includes a target lesion in a native vessel located within or extending into 10 cm above the medial epicondyle to the digital arteries.
If subject presents with bilateral disease, the first limb treated with a lesion in the target area will be considered the target limb.
For subjects with one or more wounds on the target limb, the target lesion(s) should be considered the lesion(s) in the vessel(s) that provide(s) blood flow to the wound(s).
Subject has at least one lesion in a native vessel located within or extending into the target area that is crossed and treated with an endovascular device.

Who cannot join

Subject is unwilling or unable to sign the IRB-approved informed consent form (ICF).
Subject is unable to understand or comply with the study protocol requirements.
Subject is currently participating in an investigational drug or other device study that can clinically interfere with the endpoints of this study.
Subject requires a conversion from endovascular intervention to a surgical bypass graft for any lesion(s) in the target area, as determined by the Investigator.
Subject has an in-stent restenosis in the target area, and this lesion is the only one requiring treatment.
Subject is pregnant or planning to become pregnant within the study period.
Subject has an anticipated life span of less than one (1) year.

Trial locations and contacts

52 sites in 1 country.

City, postcode or hospital

52 sites in 1 country

United States52 sites

Cardiothoracic and Vascular Surgeons, P.A.
Austin, Texas, 78756
Memorial Hospital Carbondale
Carbondale, Illinois, 62902
University Surgical Associates
Chattanooga, Tennessee, 37403
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756
Ohio Health
Columbus, Ohio, 43214
Metropolitan Heart and Vascular Institute
Coon Rapids, Minnesota, 55433
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803
Michigan Outpatient Vascular Institute
Dearborn, Michigan, 48126
Denver Heart
Denver, Colorado, 80220
VA Eastern Colorado Healthcare System
Denver, Colorado, 80220
St. John Hospital and Medical Center
Detroit, Michigan, 48236
El Paso Cardiology Associates
El Paso, Texas, 79902
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297
Phoenix Heart Cardiovascular
Glendale, Arizona, 85306
Hartford Hospital
Hartford, Connecticut, 06102
Houston Methodist Research Institute
Houston, Texas, 77030
First Coast Cardiovascular Institute
Jacksonville, Florida, 32216
St. Luke's Hospital
Kansas City, Missouri, 64111
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660
Premier Surgical Associates
Knoxville, Tennessee, 37909
Lakeland Regional Medical Center
Lakeland, Florida, 33805
Colorado Heart and Vascular, PC
Lakewood, Colorado, 80228
The Heart Institute of Largo
Largo, Florida, 33770
St. Joseph Hospital
Lexington, Kentucky, 40504
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Cedars-Sinai Heart Institute
Los Angeles, California, 90048
Duke University Hospital
Lumberton, North Carolina, 28358
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176
Mount Sinai Medical Center Heart Institute
Miami Beach, Florida, 33140
Mission Research Institute
New Braunfels, Texas, 78130
Yale-New Haven Hospital
New Haven, Connecticut, 06510
Gotham Cardiovascular Research
New York, New York, 10001
Columbia University Medical Center
New York, New York, 10032
Florida Hospital
Orlando, Florida, 32803
Coastal Vascular and Intervention
Pensacola, Florida, 32504
St. Luke's Medical Center
Phoenix, Arizona, 85006
Rex Heathcare
Raleigh, North Carolina, 27607
Shady Grove Adventist Hospital
Rockville, Maryland, 20850
Mid-Michigan Heart and Vascular Center
Saginaw, Michigan, 48604
San Antonio Endovascular & Heart Institute
San Antonio, Texas, 78358
Chicago Vascular Clinic
Schaumburg, Illinois, 60173
Sanford Research
Sioux Falls, South Dakota, 57104
Stern Cardiovascular Foundation
Southaven, Mississippi, 38671
St. John's Hospital Springfield
Springfield, Illinois, 62701
Cox Health System
Springfield, Missouri, 65802
Houston Methodist Research Institute Sugar Land
Sugar Land, Texas, 77479
Pepin Heart Institute
Tampa, Florida, 33613
St. John Health System
Tulsa, Oklahoma, 74104
Cardiovascular Associates of East Texas
Tyler, Texas, 75701
Providence Health Services
Waco, Texas, 76712
Metro Health Hospital
Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: LIBERTY 360: Prospective, Observational, Multi-Center Clinical Study to Evaluate Acute and Long Term Clinical and Economic Outcomes of Endovascular Device Intervention in Patients With Distal Outflow Peripheral Arterial Disease (PAD)

The purpose of this study is to evaluate acute and long term clinical and economic outcomes of endovascular procedures to treat Peripheral Arterial Disease (PAD).

Read the detailed description

This is a prospective, observational, multi-center, clinical study examining predictors of clinical outcomes for patients undergoing endovascular treatment of lesions within or extending into the target area (10 cm above the medial epicondyle to the digital arteries). This includes disease in a vessel located within or extending into the distal superficial femoral artery (SFA), popliteal (POP), tibial peroneal trunk (TPT), anterior tibial (AT), posterior tibial (PT), and peroneal tibial (PR) arteries.

Conditions: Peripheral Arterial Occlusive Disease
Being tested: PAD endovascular treatments
Keywords: PAD, LIBERTY, Observational
Medical subject headings: Peripheral Arterial Occlusive Disease 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PAD endovascular treatmentsOther
All FDA-cleared endovascular PAD treatments

Study groups in NCT01855412
Study group	Role	What they receive
Claudication (Rutherford 2-3)		Patients who have been diagnosed with PAD and are classified as on the Rutherford Scale as Rutherford 2-3. Patients may be treated with any FDA-cleared endovascular PAD treatment. Receives: Other: PAD endovascular treatments
CLI Rutherford 4-5		Patients who have been diagnosed with PAD and classified on the Rutherford Scale as Rutherford 4-5. Patients may be treated with any FDA-cleared endovascular PAD treatment. Receives: Other: PAD endovascular treatments
CLI Rutherford 6		Patients who have been diagnosed with PAD and classified on the Rutherford Scale as Rutherford 6. Patients may be treated with any FDA-cleared endovascular PAD treatment. Receives: Other: PAD endovascular treatments

What is being measured

The primary outcome is the main question the study is designed to answer.

Procedural Success of Endovascular PAD Treatment(s)
Final post-procedural result of <50% residual stenosis for all treated lesions for a participant during index procedure and without angiographic complications as determined by the Angiographic Core Laboratory.
Measured: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
Lesion Success of Endovascular PAD Treatment(s)
Final post-procedural result of <50% residual stenosis for a given lesion treated during index procedure without angiographic complications as determined by the Angiographic Core Laboratory.
Measured: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years
A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from a major adverse event through 1 year and 3 years.
1- and 3-year MAE is composed of:
- Death within 30 days of index procedure
- Unplanned major (above the ankle) amputation of the target limb
- Clinically-driven TVR (Target Vessel Revascularization) of the target limb
Measured: One (1) year and three (3) years post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201311 Apr 2019

First posted16 May 2013 (estimated)
Study startMay 2013
Primary completion11 Apr 2019
Study completion11 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Peripheral Arterial Occlusive DiseaseStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01855412
Sponsor's protocol ID: CLN-0001-P
Acronym: LIBERTY
Status last verified: Jul 2023
First submitted: 7 May 2013
Last updated: 18 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Adams GL, Mustapha J, Gray W, Hargus NJ, Martinsen BJ, Ansel G, Jaff MR. The LIBERTY study: Design of a prospective, observational, multicenter trial to evaluate the acute and long-term clinical and economic outcomes of real-world endovascular device interventions in treating peripheral artery disease. Am Heart J. 2016 Apr;174:14-21. doi: 10.1016/j.ahj.2015.12.013. Epub 2015 Dec 30.
PubMed 26995365
Mustapha J, Gray W, Martinsen BJ, Bolduan RW, Adams GL, Ansel G, Jaff MR. One-Year Results of the LIBERTY 360 Study: Evaluation of Acute and Midterm Clinical Outcomes of Peripheral Endovascular Device Interventions. J Endovasc Ther. 2019 Apr;26(2):143-154. doi: 10.1177/1526602819827295. Epub 2019 Feb 6.
PubMed 30722718
Mustapha JA, Igyarto Z, O'Connor D, Armstrong EJ, Iorio AR, Driver VR, Saab F, Behrens AN, Martinsen BJ, Adams GL. One-Year Outcomes of Peripheral Endovascular Device Intervention in Critical Limb Ischemia Patients: Sub-Analysis of the LIBERTY 360 Study. Vasc Health Risk Manag. 2020 Feb 10;16:57-66. doi: 10.2147/VHRM.S230934. eCollection 2020.
PubMed 32103970
Giannopoulos S, Secemsky EA, Mustapha JA, Adams G, Beasley RE, Pliagas G, Armstrong EJ. Three-Year Outcomes of Orbital Atherectomy for the Endovascular Treatment of Infrainguinal Claudication or Chronic Limb-Threatening Ischemia. J Endovasc Ther. 2020 Oct;27(5):714-725. doi: 10.1177/1526602820935611. Epub 2020 Jul 3.
PubMed 32618486
Giannopoulos S, Shammas NW, Cawich I, Staniloae CS, Adams GL, Armstrong EJ. Sex-Related Differences in the Outcomes of Endovascular Interventions for Chronic Limb-Threatening Ischemia: Results from the LIBERTY 360 Study. Vasc Health Risk Manag. 2020 Jul 8;16:271-284. doi: 10.2147/VHRM.S246528. eCollection 2020.
PubMed 32753875
Narcisse DI, Weissler EH, Rymer JA, Armstrong EJ, Secemsky EA, Gray WA, Mustapha JA, Adams GL, Ansel GM, Patel MR, Jones WS. The impact of chronic kidney disease on outcomes following peripheral vascular intervention. Clin Cardiol. 2020 Nov;43(11):1308-1316. doi: 10.1002/clc.23444. Epub 2020 Aug 11.
PubMed 32780436
Giannopoulos S, Mustapha J, Gray WA, Ansel G, Adams G, Secemsky EA, Armstrong EJ. Three-Year Outcomes From the LIBERTY 360 Study of Endovascular Interventions for Peripheral Artery Disease Stratified by Rutherford Category. J Endovasc Ther. 2021 Apr;28(2):262-274. doi: 10.1177/1526602820962972. Epub 2020 Oct 5.
PubMed 33016805
Weissler EH, Narcisse DI, Rymer JA, Armstrong EJ, Secemsky E, Gray WA, Mustapha JA, Adams GL, Ansel GM, Patel MR, Jones WS. Characteristics and Outcomes of Patients With Diabetes Mellitus Undergoing Peripheral Vascular Intervention for Infrainguinal Symptomatic Peripheral Artery Disease. Vasc Endovascular Surg. 2021 Feb;55(2):124-134. doi: 10.1177/1538574420968671. Epub 2020 Oct 23.
PubMed 33094679
Magnuson EA, Li H, Vilain K, Armstrong EJ, Secemsky EA, Giannopoulos S, Adams GL, Mustapha J, Cohen DJ; LIBERTY 360 degrees Trial Investigators. Two-year PAD-related health care costs in patients undergoing lower extremity endovascular revascularization: results from the LIBERTY 360 degrees trial. J Med Econ. 2021 Jan-Dec;24(1):570-580. doi: 10.1080/13696998.2021.1917141.
PubMed 33866936
Giannopoulos S, Pliagas G, Armstrong EJ. Procedural and 3-Year Outcomes of Peripheral Vascular Interventions Performed in Office-Based Labs: LIBERTY 360 Sub-Analysis. J Invasive Cardiol. 2021 May;33(5):E365-E377. doi: 10.25270/jic/20.00594.
PubMed 33932282
Giannopoulos, S, Fakorede FA, Cawich I, Dishmon D, Horne A, Raja ML, Mustapha JA, Adams GL, Armstrong EJ. Racial Disparities in Risk for Major Amputation or Death After Endovascular Interventions for Peripheral Artery Disease: A LIBERTY 360 Study. J Crit Limb Ischemia. 2021 June;1(2):E62-E72.
Salahuddin T, Giannopoulos S, Adams G, Armstrong EJ. Anterior, posterior, or all-vessel infrapopliteal revascularization in patients with moderate-severe claudication: Insights from the LIBERTY 360 study. Catheter Cardiovasc Interv. 2021 Sep;98(3):559-569. doi: 10.1002/ccd.29780. Epub 2021 May 31.
PubMed 34057276
Jammeh ML, Suggs J, Adams GL, Armstrong EJ, Mustapha J, Zayed MA. Outcomes of Orbital Atherectomy in Patients with Critical Limb Threatening Ischemia and Diabetes. J Crit Limb Ischemia. 2022 Jun;2(2):E29-E37. Epub 2022 Apr 12.
PubMed 37066103
Metser G, Puma J, Mustapha J, Adams GL, Ratcliffe J, Khullar P, Rosero JHC, Armstrong EJ, Zayed M, Green P. Clinical Outcomes of Additional Below-The-Ankle Intervention Compared to Below-The-Knee Intervention Alone: A Post-Hoc Analysis of a Prospective Multicenter Study. J Endovasc Ther. 2023 Oct;30(5):711-720. doi: 10.1177/15266028221092981. Epub 2022 May 3.
PubMed 35503774

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peripheral Arterial Occlusive Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LIBERTY 360: Prospective, Observational, Multi-Center Clinical Study to Evaluate Acute and Long Term Clinical and Economic Outcomes of Endovascular Device Intervention in Patients With Distal Outflow Peripheral Arterial Disease (PAD)
ClinicalTrials.gov ID: NCT01855412
Acronym / sponsor ID: LIBERTY / CLN-0001-P
Conditions: Peripheral Arterial Occlusive Disease
Keywords: PAD, LIBERTY, Observational
Study type: Observational
Recruitment status: Completed
Enrolment: 1,204 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: 11 Apr 2019 (actual)
Study completion: 11 Apr 2019 (actual)
First posted: 16 May 2013 (estimated)
Results: Posted 18 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate acute and long term clinical and economic outcomes of endovascular procedures to treat Peripheral Arterial Disease (PAD).

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Claudication (Rutherford 2-3)	–	Other: PAD endovascular treatmentsPatients who have been diagnosed with PAD and are classified as on the Rutherford Scale as Rutherford 2-3. Patients may be treated with any FDA-cleared endovascular PAD treatment.
CLI Rutherford 4-5	–	Other: PAD endovascular treatmentsPatients who have been diagnosed with PAD and classified on the Rutherford Scale as Rutherford 4-5. Patients may be treated with any FDA-cleared endovascular PAD treatment.
CLI Rutherford 6	–	Other: PAD endovascular treatmentsPatients who have been diagnosed with PAD and classified on the Rutherford Scale as Rutherford 6. Patients may be treated with any FDA-cleared endovascular PAD treatment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients who have been determined by their physician to require endovascular device treatment for their PAD.

Key inclusion criteria (6 listed)

Subject's age ≥ 18 years.
Subject presents with a Rutherford classification of 2 to 6.
Subject presents with clinical evidence of PAD requiring endovascular intervention on one or both limbs that includes a target lesion in a native vessel located within or extending into 10 cm above the medial epicondyle to the digital arteries.
Subject has at least one lesion in a native vessel located within or extending into the target area that is crossed and treated with an endovascular device.

Key exclusion criteria (7 listed)

Subject is unwilling or unable to sign the IRB-approved informed consent form (ICF).
Subject is unable to understand or comply with the study protocol requirements.
Subject is currently participating in an investigational drug or other device study that can clinically interfere with the endpoints of this study.
Subject requires a conversion from endovascular intervention to a surgical bypass graft for any lesion(s) in the target area, as determined by the Investigator.
Subject has an in-stent restenosis in the target area, and this lesion is the only one requiring treatment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PAD endovascular treatmentsAll FDA-cleared endovascular PAD treatments	Other	CLI Rutherford 4-5, CLI Rutherford 6, Claudication (Rutherford 2-3)

Primary outcome

Procedural Success of Endovascular PAD Treatment(s)
Time frame: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
Final post-procedural result of <50% residual stenosis for all treated lesions for a participant during index procedure and without angiographic complications as determined by the Angiographic Core Laboratory.
Lesion Success of Endovascular PAD Treatment(s)
Time frame: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
Final post-procedural result of <50% residual stenosis for a given lesion treated during index procedure without angiographic complications as determined by the Angiographic Core Laboratory.
Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years
Time frame: One (1) year and three (3) years post-procedure
A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from a major adverse event through 1 year and 3 years. 1- and 3-year MAE is composed of: * Death within 30 days of index procedure * Unplanned major (above the ankle) amputation of the target limb * Clinically-driven TVR (Target Vessel Revascularization) of the target limb

Results and safety

Results posted to the registry on 18 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Claudication (Rutherford 2-3)	501	289
CLI Rutherford 4-5	603	260
CLI Rutherford 6	100	24

Primary outcome: Procedural Success of Endovascular PAD Treatment(s)

Time frame: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours. Number (95% Confidence Interval). Unit: percent of procedures

Measure	Claudication (Rutherford 2-3) n = 469	CLI Rutherford 4-5 n = 545	CLI Rutherford 6 n = 92
Value	83.6 (79.9 to 86.8)	75.8 (72.0 to 79.3)	68.5 (58.0 to 77.8)

Population analysed: Analysis population consists of data from 1,106 enrolled subjects with sufficient information to assess procedural success. Fifteen subjects were excluded due to site closure and lack of investigator signature, 83 subjects were excluded due to lack of sufficient stenosis and/or angiographic complication data to determine success or failure.

Primary outcome: Lesion Success of Endovascular PAD Treatment(s)

Time frame: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours. Number (95% Confidence Interval). Unit: percent of lesions treated

Measure	Claudication (Rutherford 2-3) n = 578	CLI Rutherford 4-5 n = 733	CLI Rutherford 6 n = 141
Value	84.9 (81.9 to 88.0)	79.1 (75.8 to 82.1)	75.2 (66.8 to 82.2)

Population analysed: Analysis population consists of data from 1,452 treated lesions with sufficient information to assess procedural success. Data from fifteen subjects were excluded due to site closure and lack of investigator signature; 76 lesions were excluded due to lack of sufficient stenosis and/or angiographic complication data to determine success or failure.

Primary outcome: Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years

Time frame: One (1) year and three (3) years post-procedure. Number (95% Confidence Interval). Unit: percent probability of freedom from MAE

Measure	Claudication (Rutherford 2-3) n = 500	CLI Rutherford 4-5 n = 589	CLI Rutherford 6 n = 100
Freedom from MAE at 1-Year	82.1 (78.6 to 85.7)	73.2 (69.4 to 77.0)	59.3 (48.4 to 70.1)
Freedom from MAE at 3-Years	70.3 (65.9 to 74.7)	62.0 (57.5 to 66.5)	47.4 (34.7 to 60.0)

Population analysed: Analysis population consists of data from 1,189 enrolled subjects with Investigator signed baseline and procedure patient records. Due to site closure and lack of Investigator signature, 15 subjects were excluded in the cohort.

Adverse events

Time frame: Index procedure through 5 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Claudication Rutherford 2-3 Procedure Through 30 Days	72 of 501 (14.4%)	28 of 501 (5.6%)	2 of 501
CLI Rutherford 4-5 Procedure Through 30 Days	112 of 603 (18.6%)	31 of 603 (5.1%)	2 of 603
CLI Rutherford 6 Procedure Through 30 Days	24 of 100 (24%)	2 of 100 (2%)	4 of 100
Rutherford 2-3 31 Days - 365 Days Post-Procedure	145 of 501 (28.9%)	0 of 501 (0%)	18 of 501
CLI Rutherford 4-5 31 Days - 365 Days Post-Procedure	249 of 603 (41.3%)	0 of 603 (0%)	40 of 603
CLI Rutherford 6 31 Days - 365 Days Post-Procedure	40 of 100 (40%)	0 of 100 (0%)	17 of 100
Claudication Rutherford 2-3 366 Days Post-Procedure or Greater	167 of 501 (33.3%)	0 of 501 (0%)	57 of 501
CLI Rutherford 4-5 366 Days Post-Procedure or Greater	227 of 603 (37.6%)	0 of 603 (0%)	81 of 603
CLI Rutherford 6 366 Days Post-Procedure or Greater	24 of 100 (24%)	0 of 100 (0%)	9 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26995365Adams GL, Mustapha J, Gray W, Hargus NJ, Martinsen BJ, Ansel G, Jaff MR. The LIBERTY study: Design of a prospective, observational, multicenter trial to evaluate the acute and long-term clinical and economic outcomes of real-world endovascular device interventions in treating peripheral artery disease. Am Heart J. 2016 Apr;174:14-21. doi: 10.1016/j.ahj.2015.12.013. Epub 2015 Dec 30.
Results publication: PubMed 30722718Mustapha J, Gray W, Martinsen BJ, Bolduan RW, Adams GL, Ansel G, Jaff MR. One-Year Results of the LIBERTY 360 Study: Evaluation of Acute and Midterm Clinical Outcomes of Peripheral Endovascular Device Interventions. J Endovasc Ther. 2019 Apr;26(2):143-154. doi: 10.1177/1526602819827295. Epub 2019 Feb 6.
Results publication: PubMed 32103970Mustapha JA, Igyarto Z, O'Connor D, Armstrong EJ, Iorio AR, Driver VR, Saab F, Behrens AN, Martinsen BJ, Adams GL. One-Year Outcomes of Peripheral Endovascular Device Intervention in Critical Limb Ischemia Patients: Sub-Analysis of the LIBERTY 360 Study. Vasc Health Risk Manag. 2020 Feb 10;16:57-66. doi: 10.2147/VHRM.S230934. eCollection 2020.
Results publication: PubMed 32618486Giannopoulos S, Secemsky EA, Mustapha JA, Adams G, Beasley RE, Pliagas G, Armstrong EJ. Three-Year Outcomes of Orbital Atherectomy for the Endovascular Treatment of Infrainguinal Claudication or Chronic Limb-Threatening Ischemia. J Endovasc Ther. 2020 Oct;27(5):714-725. doi: 10.1177/1526602820935611. Epub 2020 Jul 3.
Results publication: PubMed 32753875Giannopoulos S, Shammas NW, Cawich I, Staniloae CS, Adams GL, Armstrong EJ. Sex-Related Differences in the Outcomes of Endovascular Interventions for Chronic Limb-Threatening Ischemia: Results from the LIBERTY 360 Study. Vasc Health Risk Manag. 2020 Jul 8;16:271-284. doi: 10.2147/VHRM.S246528. eCollection 2020.
Results publication: PubMed 32780436Narcisse DI, Weissler EH, Rymer JA, Armstrong EJ, Secemsky EA, Gray WA, Mustapha JA, Adams GL, Ansel GM, Patel MR, Jones WS. The impact of chronic kidney disease on outcomes following peripheral vascular intervention. Clin Cardiol. 2020 Nov;43(11):1308-1316. doi: 10.1002/clc.23444. Epub 2020 Aug 11.
Results publication: PubMed 33016805Giannopoulos S, Mustapha J, Gray WA, Ansel G, Adams G, Secemsky EA, Armstrong EJ. Three-Year Outcomes From the LIBERTY 360 Study of Endovascular Interventions for Peripheral Artery Disease Stratified by Rutherford Category. J Endovasc Ther. 2021 Apr;28(2):262-274. doi: 10.1177/1526602820962972. Epub 2020 Oct 5.
Results publication: PubMed 33094679Weissler EH, Narcisse DI, Rymer JA, Armstrong EJ, Secemsky E, Gray WA, Mustapha JA, Adams GL, Ansel GM, Patel MR, Jones WS. Characteristics and Outcomes of Patients With Diabetes Mellitus Undergoing Peripheral Vascular Intervention for Infrainguinal Symptomatic Peripheral Artery Disease. Vasc Endovascular Surg. 2021 Feb;55(2):124-134. doi: 10.1177/1538574420968671. Epub 2020 Oct 23.
Results publication: PubMed 33866936Magnuson EA, Li H, Vilain K, Armstrong EJ, Secemsky EA, Giannopoulos S, Adams GL, Mustapha J, Cohen DJ; LIBERTY 360 degrees Trial Investigators. Two-year PAD-related health care costs in patients undergoing lower extremity endovascular revascularization: results from the LIBERTY 360 degrees trial. J Med Econ. 2021 Jan-Dec;24(1):570-580. doi: 10.1080/13696998.2021.1917141.
Results publication: PubMed 33932282Giannopoulos S, Pliagas G, Armstrong EJ. Procedural and 3-Year Outcomes of Peripheral Vascular Interventions Performed in Office-Based Labs: LIBERTY 360 Sub-Analysis. J Invasive Cardiol. 2021 May;33(5):E365-E377. doi: 10.25270/jic/20.00594.
Results publicationGiannopoulos, S, Fakorede FA, Cawich I, Dishmon D, Horne A, Raja ML, Mustapha JA, Adams GL, Armstrong EJ. Racial Disparities in Risk for Major Amputation or Death After Endovascular Interventions for Peripheral Artery Disease: A LIBERTY 360 Study. J Crit Limb Ischemia. 2021 June;1(2):E62-E72.
Results publication: PubMed 34057276Salahuddin T, Giannopoulos S, Adams G, Armstrong EJ. Anterior, posterior, or all-vessel infrapopliteal revascularization in patients with moderate-severe claudication: Insights from the LIBERTY 360 study. Catheter Cardiovasc Interv. 2021 Sep;98(3):559-569. doi: 10.1002/ccd.29780. Epub 2021 May 31.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William Gray, MD principal investigator

Columbia University

Gary Ansel, MD principal investigator

Ohio Health

George Adams, MD principal investigator

Rex Healthcare

52 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Occlusive Disease, run by Abbott Medical Devices at 52 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural Success of Endovascular PAD Treatment(s) (time frame: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01855412, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.