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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Cardiovascular Systems Inc
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Systems Inc
ClinicalTrials.gov Identifier:
NCT01855412
First received: May 7, 2013
Last updated: March 12, 2015
Last verified: March 2015
  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 < 50% 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 < 50% 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 within 30 days of index procedure
    • Unplanned major (above the ankle) amputation of the target limb
    • Clinically-driven TLR (Target Lesion Revascularization) and/or TVR (Target Vessel Revascularization) of the target limb


Estimated Enrollment: 1200
Study Start Date: May 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (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 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.

  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:

  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.
  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

Contacts
Contact: Eileen Stirriup, BA 651-236-7235 estirriup@csi360.com

  Show 46 Study Locations
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: March 12, 2015
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
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 26, 2015