Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes

Peripheral Arterial Occlusive Disease Clinical Trial

— LIBERTY  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855412
• Other study ID #: CLN-0001-P
• Status: Completed
• Start date: May 2013
• Est. completion date: April 11, 2019

Study information

• Verified date: July 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1204
• Est. completion date: April 11, 2019
• Est. primary completion date: April 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject's age = 18 years.

2. Subject presents with a Rutherford classification of 2 to 6.

3. 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).

4. 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.

Exclusion Criteria:

1. Subject is unwilling or unable to sign the IRB-approved informed consent form (ICF).

2. Subject is unable to understand or comply with the study protocol requirements.

3. Subject is currently participating in an investigational drug or other device study that can clinically interfere with the endpoints of this study.

4. 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.

5. Subject has an in-stent restenosis in the target area, and this lesion is the only one requiring treatment.

6. Subject is pregnant or planning to become pregnant within the study period.

7. Subject has an anticipated life span of less than one (1) year.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Occlusive Disease

Intervention

Other:
• PAD endovascular treatments
All FDA-cleared endovascular PAD treatments

Locations

Country	Name	City	State
United States	Cardiothoracic and Vascular Surgeons, P.A.	Austin	Texas
United States	Memorial Hospital Carbondale	Carbondale	Illinois
United States	University Surgical Associates	Chattanooga	Tennessee
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	Ohio Health	Columbus	Ohio
United States	Metropolitan Heart and Vascular Institute	Coon Rapids	Minnesota
United States	Midwest Cardiovascular Research Foundation	Davenport	Iowa
United States	Michigan Outpatient Vascular Institute	Dearborn	Michigan
United States	Denver Heart	Denver	Colorado
United States	VA Eastern Colorado Healthcare System	Denver	Colorado
United States	St. John Hospital and Medical Center	Detroit	Michigan
United States	El Paso Cardiology Associates	El Paso	Texas
United States	University of Texas Medical Branch at Galveston	Galveston	Texas
United States	Mercy Gilbert Medical Center	Gilbert	Arizona
United States	Phoenix Heart Cardiovascular	Glendale	Arizona
United States	Hartford Hospital	Hartford	Connecticut
United States	Houston Methodist Research Institute	Houston	Texas
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Wellmont CVA Heart Institute	Kingsport	Tennessee
United States	Premier Surgical Associates	Knoxville	Tennessee
United States	Lakeland Regional Medical Center	Lakeland	Florida
United States	Colorado Heart and Vascular, PC	Lakewood	Colorado
United States	The Heart Institute of Largo	Largo	Florida
United States	St. Joseph Hospital	Lexington	Kentucky
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Cedars-Sinai Heart Institute	Los Angeles	California
United States	Duke University Hospital	Lumberton	North Carolina
United States	Baptist Cardiac and Vascular Institute	Miami	Florida
United States	Mount Sinai Medical Center Heart Institute	Miami Beach	Florida
United States	Mission Research Institute	New Braunfels	Texas
United States	Yale-New Haven Hospital	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Gotham Cardiovascular Research	New York	New York
United States	Florida Hospital	Orlando	Florida
United States	Coastal Vascular and Intervention	Pensacola	Florida
United States	St. Luke's Medical Center	Phoenix	Arizona
United States	Rex Heathcare	Raleigh	North Carolina
United States	Shady Grove Adventist Hospital	Rockville	Maryland
United States	Mid-Michigan Heart and Vascular Center	Saginaw	Michigan
United States	San Antonio Endovascular & Heart Institute	San Antonio	Texas
United States	Chicago Vascular Clinic	Schaumburg	Illinois
United States	Sanford Research	Sioux Falls	South Dakota
United States	Stern Cardiovascular Foundation	Southaven	Mississippi
United States	Cox Health System	Springfield	Missouri
United States	St. John's Hospital Springfield	Springfield	Illinois
United States	Houston Methodist Research Institute Sugar Land	Sugar Land	Texas
United States	Pepin Heart Institute	Tampa	Florida
United States	St. John Health System	Tulsa	Oklahoma
United States	Cardiovascular Associates of East Texas	Tyler	Texas
United States	Providence Health Services	Waco	Texas
United States	Metro Health Hospital	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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) — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

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

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. — View Citation

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: — View Citation

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 Mu — View Citation

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 — View Citation

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. — View Citation

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):1308-13 — View Citation

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 — View Citation

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 Sympt — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
Primary	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.	Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
Primary	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	One (1) year and three (3) years post-procedure