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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Systems Inc
ClinicalTrials.gov Identifier:
NCT01855412
First received: May 7, 2013
Last updated: June 7, 2016
Last verified: June 2016

May 7, 2013
June 7, 2016
May 2013
December 2020   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01855412 on ClinicalTrials.gov Archive Site
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.
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.
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
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
 
Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes
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).
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients who have been determined by their physician to require endovascular device treatment for their PAD.
Peripheral Arterial Occlusive Disease
Other: PAD endovascular treatments
All FDA-cleared endovascular PAD treatments
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Other: PAD endovascular treatments
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1204
December 2020
December 2020   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01855412
CLN-0001-P
No
Not Provided
Not Provided
Cardiovascular Systems Inc
Cardiovascular Systems Inc
Not Provided
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
Cardiovascular Systems Inc
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP