Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes

Completed

Conditions: Peripheral Arterial Occlusive Disease

Interventions: Other: PAD endovascular treatments

Registration Number: NCT01855412

Lead Sponsor: Abbott Medical Devices

Brief Summary: 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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1204

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 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).
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

Subject is unwilling or unable to sign the IRB-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 requires a conversion from endovascular intervention to a surgical bypass graft for any lesion(s) in the target area, as determined by the Investigator.
Subject has an in-stent restenosis in the target area, and this lesion is the only one requiring treatment.
Subject is pregnant or planning to become pregnant within the study period.
Subject has an anticipated life span of less than one (1) year.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Claudication (Rutherford 2-3)	PAD endovascular treatments	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.
CLI Rutherford 6	PAD endovascular treatments	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.
CLI Rutherford 4-5	PAD endovascular treatments	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.

Primary Outcome Measures

Name	Time	Method
Procedural Success of Endovascular PAD Treatment(s)	Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours	Final post-procedural result of \<50% residual stenosis for all treated lesions for a participant during index procedure and without angiographic complications as determined by the Angiographic Core Laboratory.
Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years	One (1) year and three (3) years post-procedure	A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from a major adverse event through 1 year and 3 years. 1- and 3-year MAE is composed of: * Death within 30 days of index procedure * Unplanned major (above the ankle) amputation of the target limb * Clinically-driven TVR (Target Vessel Revascularization) of the target limb
Lesion Success of Endovascular PAD Treatment(s)	Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (52): Baptist Cardiac and Vascular Institute
🇺🇸
Miami, Florida, United States
St. John Hospital and Medical Center
🇺🇸
Detroit, Michigan, United States
Houston Methodist Research Institute
🇺🇸
Houston, Texas, United States
San Antonio Endovascular & Heart Institute
🇺🇸
San Antonio, Texas, United States
Duke University Hospital
🇺🇸
Lumberton, North Carolina, United States
Denver Heart
🇺🇸
Denver, Colorado, United States
VA Eastern Colorado Healthcare System
🇺🇸
Denver, Colorado, United States
Mercy Gilbert Medical Center
🇺🇸
Gilbert, Arizona, United States
Phoenix Heart Cardiovascular
🇺🇸
Glendale, Arizona, United States
St. Luke's Medical Center
🇺🇸
Phoenix, Arizona, United States
Arkansas Heart Hospital
🇺🇸
Little Rock, Arkansas, United States
Cedars-Sinai Heart Institute
🇺🇸
Los Angeles, California, United States
Colorado Heart and Vascular, PC
🇺🇸
Lakewood, Colorado, United States
Clearwater Cardiovascular Consultants
🇺🇸
Clearwater, Florida, United States
First Coast Cardiovascular Institute
🇺🇸
Jacksonville, Florida, United States
Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
The Heart Institute of Largo
🇺🇸
Largo, Florida, United States
Lakeland Regional Medical Center
🇺🇸
Lakeland, Florida, United States
Mount Sinai Medical Center Heart Institute
🇺🇸
Miami Beach, Florida, United States
Coastal Vascular and Intervention
🇺🇸
Pensacola, Florida, United States
St. John's Hospital Springfield
🇺🇸
Springfield, Illinois, United States
Midwest Cardiovascular Research Foundation
🇺🇸
Davenport, Iowa, United States
Memorial Hospital Carbondale
🇺🇸
Carbondale, Illinois, United States
Chicago Vascular Clinic
🇺🇸
Schaumburg, Illinois, United States
Mid-Michigan Heart and Vascular Center
🇺🇸
Saginaw, Michigan, United States
Metro Health Hospital
🇺🇸
Wyoming, Michigan, United States
Metropolitan Heart and Vascular Institute
🇺🇸
Coon Rapids, Minnesota, United States
Shady Grove Adventist Hospital
🇺🇸
Rockville, Maryland, United States
Michigan Outpatient Vascular Institute
🇺🇸
Dearborn, Michigan, United States
Stern Cardiovascular Foundation
🇺🇸
Southaven, Mississippi, United States
Cox Health System
🇺🇸
Springfield, Missouri, United States
Gotham Cardiovascular Research
🇺🇸
New York, New York, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
Rex Heathcare
🇺🇸
Raleigh, North Carolina, United States
Ohio Health
🇺🇸
Columbus, Ohio, United States
St. John Health System
🇺🇸
Tulsa, Oklahoma, United States
Sanford Research
🇺🇸
Sioux Falls, South Dakota, United States
University Surgical Associates
🇺🇸
Chattanooga, Tennessee, United States
Wellmont CVA Heart Institute
🇺🇸
Kingsport, Tennessee, United States
El Paso Cardiology Associates
🇺🇸
El Paso, Texas, United States
Cardiothoracic and Vascular Surgeons, P.A.
🇺🇸
Austin, Texas, United States
Premier Surgical Associates
🇺🇸
Knoxville, Tennessee, United States
Mission Research Institute
🇺🇸
New Braunfels, Texas, United States
University of Texas Medical Branch at Galveston
🇺🇸
Galveston, Texas, United States
Cardiovascular Associates of East Texas
🇺🇸
Tyler, Texas, United States
Houston Methodist Research Institute Sugar Land
🇺🇸
Sugar Land, Texas, United States
Providence Health Services
🇺🇸
Waco, Texas, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
St. Luke's Hospital
🇺🇸
Kansas City, Missouri, United States
Yale-New Haven Hospital
🇺🇸
New Haven, Connecticut, United States
Pepin Heart Institute
🇺🇸
Tampa, Florida, United States
St. Joseph Hospital
🇺🇸
Lexington, Kentucky, United States