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

This study is currently recruiting participants.
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

May 7, 2013
August 15, 2013
May 2013
May 2019   (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 < 30% residual stenosis for all treated lesions during index procedure and without angiographic complications as determined by the Angiographic Core Laboratory.
Same as current
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 < 30% residual stenosis for a given lesion treated during index procedure without angiographic complications as determined by the Angiographic Core Laboratory.
Same as current
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
Same as current
 
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 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.

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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
Not Provided
May 2019   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Not Provided
United States
 
NCT01855412
CLN-0001-P
No
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
August 2013

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