Peripheral Arterial Occlusive Disease
Conditions
Keywords
PAD, LIBERTY, Observational
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.
Interventions
OTHERPAD endovascular treatments
All FDA-cleared endovascular PAD treatments
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
Countries
United States
Participant flow
Pre-assignment details
A subject was considered enrolled when a signed informed consent was in place and all inclusion/no exclusion criteria were met.
Participants by arm
| Arm | Count |
|---|---|
| Claudication (Rutherford 2-3) Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice. | 500 |
| CLI Rutherford 4-5 Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice. | 589 |
| CLI Rutherford 6 Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice. | 100 |
| Total | 1,189 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 77 | 123 | 30 |
| Overall Study | Lost to Follow-up | 28 | 46 | 15 |
| Overall Study | Physician Decision | 25 | 31 | 3 |
| Overall Study | Reason not Specified | 1 | 2 | 3 |
| Overall Study | Site Closure | 4 | 18 | 1 |
| Overall Study | Withdrawal by Subject | 77 | 123 | 24 |
Baseline characteristics
| Characteristic | CLI Rutherford 4-5 | Total | Claudication (Rutherford 2-3) | CLI Rutherford 6 |
|---|---|---|---|---|
| Age, Continuous | 70.3 years STANDARD_DEVIATION 10.9 | 69.8 years STANDARD_DEVIATION 10.7 | 69.7 years STANDARD_DEVIATION 10 | 68.0 years STANDARD_DEVIATION 13 |
| Baseline Rutherford Classification (RC) RC 2 | 0 Participants | 97 Participants | 97 Participants | 0 Participants |
| Baseline Rutherford Classification (RC) RC 3 | 0 Participants | 403 Participants | 403 Participants | 0 Participants |
| Baseline Rutherford Classification (RC) RC 4 | 285 Participants | 285 Participants | 0 Participants | 0 Participants |
| Baseline Rutherford Classification (RC) RC 5 | 304 Participants | 304 Participants | 0 Participants | 0 Participants |
| Baseline Rutherford Classification (RC) RC 6 | 0 Participants | 100 Participants | 0 Participants | 100 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 63 Participants | 169 Participants | 77 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 526 Participants | 1020 Participants | 423 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 7 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 89 Participants | 178 Participants | 68 Participants | 21 Participants |
| Race/Ethnicity, Customized Caucasian | 483 Participants | 972 Participants | 411 Participants | 78 Participants |
| Race/Ethnicity, Customized Native American | 4 Participants | 5 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 11 Participants | 25 Participants | 14 Participants | 0 Participants |
| Region of Enrollment United States | 589 participants | 1189 participants | 500 participants | 100 participants |
| Sex: Female, Male Female | 225 Participants | 419 Participants | 167 Participants | 27 Participants |
| Sex: Female, Male Male | 364 Participants | 770 Participants | 333 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 501 | 2 / 603 | 4 / 100 | 18 / 501 | 40 / 603 | 17 / 100 | 57 / 501 | 81 / 603 | 9 / 100 |
| other Total, other adverse events | 28 / 501 | 31 / 603 | 2 / 100 | 0 / 501 | 0 / 603 | 0 / 100 | 0 / 501 | 0 / 603 | 0 / 100 |
| serious Total, serious adverse events | 72 / 501 | 112 / 603 | 24 / 100 | 145 / 501 | 249 / 603 | 40 / 100 | 167 / 501 | 227 / 603 | 24 / 100 |
Outcome results
Primary
Lesion Success of Endovascular PAD Treatment(s)
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.
Time frame: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
Population: Analysis population consists of data from 1,452 treated lesions with sufficient information to assess procedural success. Data from fifteen subjects were excluded due to site closure and lack of investigator signature; 76 lesions were excluded due to lack of sufficient stenosis and/or angiographic complication data to determine success or failure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Claudication (Rutherford 2-3) | Lesion Success of Endovascular PAD Treatment(s) | 84.9 percent of lesions treated |
| CLI Rutherford 4-5 | Lesion Success of Endovascular PAD Treatment(s) | 79.1 percent of lesions treated |
| CLI Rutherford 6 | Lesion Success of Endovascular PAD Treatment(s) | 75.2 percent of lesions treated |
Primary
Procedural Success of Endovascular PAD Treatment(s)
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.
Time frame: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
Population: Analysis population consists of data from 1,106 enrolled subjects with sufficient information to assess procedural success. Fifteen subjects were excluded due to site closure and lack of investigator signature, 83 subjects were excluded due to lack of sufficient stenosis and/or angiographic complication data to determine success or failure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Claudication (Rutherford 2-3) | Procedural Success of Endovascular PAD Treatment(s) | 83.6 percent of procedures |
| CLI Rutherford 4-5 | Procedural Success of Endovascular PAD Treatment(s) | 75.8 percent of procedures |
| CLI Rutherford 6 | Procedural Success of Endovascular PAD Treatment(s) | 68.5 percent of procedures |
Primary
Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years
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
Time frame: One (1) year and three (3) years post-procedure
Population: Analysis population consists of data from 1,189 enrolled subjects with Investigator signed baseline and procedure patient records. Due to site closure and lack of Investigator signature, 15 subjects were excluded in the cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Claudication (Rutherford 2-3) | Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years | Freedom from MAE at 1-Year | 82.1 percent probability of freedom from MAE |
| Claudication (Rutherford 2-3) | Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years | Freedom from MAE at 3-Years | 70.3 percent probability of freedom from MAE |
| CLI Rutherford 4-5 | Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years | Freedom from MAE at 1-Year | 73.2 percent probability of freedom from MAE |
| CLI Rutherford 4-5 | Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years | Freedom from MAE at 3-Years | 62.0 percent probability of freedom from MAE |
| CLI Rutherford 6 | Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years | Freedom from MAE at 1-Year | 59.3 percent probability of freedom from MAE |
| CLI Rutherford 6 | Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years | Freedom from MAE at 3-Years | 47.4 percent probability of freedom from MAE |