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

Abbott

Status: Completed

Conditions: Peripheral Arterial Occlusive Disease

Treatments: Other: PAD endovascular treatments

Study type: Observational

Funder types: Industry

Identifiers

NCT01855412

CLN-0001-P

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,204 participants in 3 patient groups

Claudication (Rutherford 2-3)

Description:

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.

Treatment:

Other: PAD endovascular treatments

CLI Rutherford 4-5

Description:

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.

Treatment:

Other: PAD endovascular treatments

CLI Rutherford 6

Description:

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.

Treatment:

Other: PAD endovascular treatments