Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes (LIBERTY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Cardiovascular Systems Inc
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Systems Inc
ClinicalTrials.gov Identifier:
NCT01855412
First received: May 7, 2013
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention
Peripheral Arterial Occlusive Disease
Other: PAD endovascular treatments

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Cardiovascular Systems Inc:

Primary Outcome Measures:
  • Procedural success of Endovascular PAD Treatment(s) [ Time Frame: After the last subject's 5-year follow-up visit ] [ Designated as safety issue: No ]
    Final post-procedural result of < 30% residual stenosis for all treated lesions during index procedure and without angiographic complications as determined by the Angiographic Core Laboratory.


Secondary Outcome Measures:
  • Lesion Success of Endovascular PAD Treatment(s) [ Time Frame: After the last subject's 5-year follow-up visit ] [ Designated as safety issue: No ]
    Final post-procedural result of < 30% residual stenosis for a given lesion treated during index procedure without angiographic complications as determined by the Angiographic Core Laboratory.


Other Outcome Measures:
  • Rate of Major Adverse Events (MAEs) [ Time Frame: After the last subject's 5-year follow-up visit ] [ Designated as safety issue: No ]

    The rate of the following MAEs as reported by the Investigators will be assessed during the subject's participation in the study:

    • Death
    • Unplanned major (above the ankle) amputation of the index limb
    • Clinically-driven TLR (Target Lesion Revascularization) and/or TVR (Target Vessel Revascularization) of the index limb


Estimated Enrollment: 1200
Study Start Date: May 2013
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: PAD endovascular treatments
All FDA-cleared endovascular PAD 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.
Other: PAD endovascular treatments
All FDA-cleared endovascular PAD 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.
Other: PAD endovascular treatments
All FDA-cleared endovascular PAD treatments

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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 that includes a target lesion located within 10 cm above the medial epicondyle to the digital arteries. For the subjects with a wound on the index limb, the target lesion should be considered the lesion in the vessel which provides blood flow to the wound.

Exclusion Criteria:

  • Subject is unwilling or unable to sign the IRB (Institutional Review Board) 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 is pregnant or planning to become pregnant within the study period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855412

Locations
United States, Connecticut
Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Patty Fugal, MS    203-785-4855    patricia.fugal@yale.edu   
Principal Investigator: Jeffrey Indes, MD         
Sub-Investigator: Bart Muhs, MD         
Sub-Investigator: John Aruny, MD         
Sub-Investigator: Cassius Chaar, MD         
Sub-Investigator: Hamid Mojibian, MD         
Sub-Investigator: Bauer Sumpio, MD         
United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Tracey Purvis, RN    407-303-5600 ext 1102019    tracey.purvis@flhosp.org   
Principal Investigator: Mark Ranson, MD         
Sub-Investigator: Rohit Bhatheja, MD         
Sub-Investigator: Nipun Arora, MD         
Sub-Investigator: Alan Wladis, MD         
Sub-Investigator: David Varnagy, MD         
Sub-Investigator: Delos Clift, MD         
Sub-Investigator: Manuel Perez, MD         
Sub-Investigator: Robert Winter, MD         
United States, Maryland
Shady Grove Adventist Hospital Recruiting
Rockville, Maryland, United States, 20850
Contact: Kathy Carney, RN, BSN    240-826-6177    kcarney@adventisthealthcare.com   
Principal Investigator: Jeffrey Wang, MD         
Sub-Investigator: Richard Silva, MD         
Sub-Investigator: Shan Haider, MD         
United States, Michigan
Metro Health Hospital Recruiting
Wyoming, Michigan, United States, 49519
Contact: Theresa McGoff, RN    616-252-8116    theresa.mcgoff@metrogr.org   
Principal Investigator: Jihad Mustapha, MD         
Sub-Investigator: Barbara Karenko, MD         
Sub-Investigator: Larry Diaz, MD         
Sub-Investigator: Fadi Saab, MD         
United States, New York
Gotham Cardiovascular Recruiting
New York, New York, United States, 10001
Contact: Jessica Liu, NP    646-660-9991    mliu@nycva.net   
Principal Investigator: Cezar Staniloae, MD         
Sub-Investigator: Lori Vales, MD         
Sub-Investigator: Seol Hwang, MD         
United States, North Carolina
Rex Hospital Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Patrick Krejci, RN, MSN    919-784-4279    patrick.krejci@rexhealth.com   
Principal Investigator: George Adams, MD         
Sub-Investigator: James Zidar, MD         
Sub-Investigator: Mohit Pasi, MD         
Sub-Investigator: Deepak Pasi, MD         
Sponsors and Collaborators
Cardiovascular Systems Inc
Investigators
Principal Investigator: William Gray, MD Columbia University
Principal Investigator: Gary Ansel, MD Riverside Methodist Hospital
Principal Investigator: George Adams, MD Rex Healthcare
Principal Investigator: Jihad Mustapha, MD Metro Health Hospital
  More Information

No publications provided

Responsible Party: Cardiovascular Systems Inc
ClinicalTrials.gov Identifier: NCT01855412     History of Changes
Other Study ID Numbers: CLN-0001-P
Study First Received: May 7, 2013
Last Updated: August 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cardiovascular Systems Inc:
PAD
LIBERTY
Observational

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis

ClinicalTrials.gov processed this record on July 28, 2014