Peripheral Arterial Disease
Conditions
Keywords
peripheral arterial disease, drug coated balloon
Brief summary
Investigators hypothesize in patients presenting with significant peripheral arterial disease with clinical indications for treatment with angioplasty, there will be a difference in 12 month patency between the subjects with Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter and IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter.
Detailed description
Investigators hypothesize in patients presenting with significant peripheral arterial disease with clinical indications for treatment with angioplasty, there will be a difference in the 12 month patency (defined as peak systolic velocity ratio \<=2.4 at 12 month follow-up visit with no target lesion revascularization or target lesion bypass) between the subjects with Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter and IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter. Investigators will also assess and compare target lesion revascularization rates, safety profiles, adverse events, healthcare costs, and healthcare utilization.
Interventions
DEVICELutonix
Drug Coated Balloons
DEVICEIN.PACT
Drug Coated Balloons
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is willing and able to provide informed consent, willing and agrees to comply with regular follow up visits, testing, medication regimen compliance any another treatments deemed necessary for treatment of vascular disease. 2. Male or non-pregnant female 3. Age greater \>=18 years of age 4. Patients with moderate to severe claudication or ischemic rest pain as defined by Rutherford 2-4 class symptoms 5. \>=1 tibial run-off vessel at baseline 6. Angiographic criteria * \>=70% stenosis (via visual angiographic estimate in the superficial femoral artery and/or popliteal arteries as appropriate) * 4-7 mm vessel diameter * \<=15 cm for planned treatment segment length. * Planned treatment segments are to no further proximal than 1 cm from the bifurcation of the common femoral artery and no further distal than the 1 cm above the tibioperoneal trunk. * Lesions treated within the target vessel are either De Novo lesions or not previously stented restenotic segments of the superficial femoral artery and/or popliteal artery that are greater than 90 days from prior angioplasty procedure * If the target vessel was previously stented the treated lesion must be at least 3 cm from the previously placed stent * Lesion must be able to be treated with either drug coated balloon device based on the sizes specifications of both devices * Successful, uncomplicated crossing must be possible within the treated lesion either with or without a crossing device * Inflow artery must be free from significant occlusive disease (\< 50%) as confirmed by visual estimation by angiography otherwise the inflow artery must be treated beforehand. * At least 1 patent vessel outflow from the target vessel treated must be present by angiography
Exclusion criteria
1. Unable to meet clinical criteria to have peripheral angioplasty and follow-up treatment (lab values and pregnancy test) 2. Contra-indicated to either drug coated balloon 3. \< 18 years of age at time of consent and/or index procedure 4. Pregnant or breastfeeding 5. In-stent restenosis within the target lesion 6. Previously stented target lesion/vessel. 7. Target lesion/vessel previously treated with drug-coated balloon \<12 months prior to randomization/enrollment. 8. Perforated vessel as evidenced by extravasation of contrast media prior to consent or enrollment. 9. Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention \<=30 days of consent or randomization. 10. Presence of aneurysm in the target vessel. 11. Major amputation in the target limb. 12. Subjects who have undergone prior surgery of the superficial femoral artery/proximal popliteal artery in the target limb to treat atherosclerotic disease. 13. Use of atherectomy, laser or other debulking devices in the target limb superficial femoral artery/proximal popliteal artery during the index procedure. 14. Acute ischemia and/or acute thrombosis of the superficial femoral artery/proximal popliteal artery prior to consent or randomization. 15. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the local investigator, cannot be adequately pre-medicated. 16. Known hypersensitivity/allergy to the investigational stent system or protocol related therapies. 17. On dialysis or on an immunosuppressant therapy. 18. Concomitant renal failure (including serum creatinine \>2.0 mg/dL.) 19. Occurrence of myocardial infarction or cerebrovascular accident \<=6 months prior to consent. 20. Platelet count \<80,000 mm3 or \>600,000 mm3 or history of bleeding diathesis. 21. Unstable angina pectoris at the time of consent or randomization. 22. Septicemia at the time of consent or randomization. 23. Moderate to severely calcified lesions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency (Peak Systolic Velocity Ratio<=2.4) | 12 months | Peak systolic velocity ratio \<=2.4 (by duplex ultrasound scanning) with no target lesion revascularization or target lesion bypass |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Revascularization Rate | 12 months | To examine, describe and compare/contrast within and between Drug Coated Balloon groups. 1. Target lesion revascularization rate 2. Safety event rate 3. Healthcare utilization costs |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lutonix Drug Coated Balloon Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter
Lutonix: Drug Coated Balloons | 18 |
| IN.PACT Drug Coated Balloon IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
IN.PACT: Drug Coated Balloons | 17 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
Baseline characteristics
| Characteristic | Lutonix Drug Coated Balloon | IN.PACT Drug Coated Balloon | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 9 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 8 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 12 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 9 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) White | 8 Participants | 4 Participants | 12 Participants |
| Region of Enrollment United States | 18 participants | 17 participants | 35 participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 18 | 0 / 17 |
| other Total, other adverse events | 0 / 18 | 0 / 17 |
| serious Total, serious adverse events | 1 / 18 | 0 / 17 |
Outcome results
Primary
Primary Patency (Peak Systolic Velocity Ratio<=2.4)
Peak systolic velocity ratio \<=2.4 (by duplex ultrasound scanning) with no target lesion revascularization or target lesion bypass
Time frame: 12 months
Population: Data were not collected.~Insufficient number of participants enrolled to perform data analysis prior to study closure. No data displayed because outcome measure had zero total participants analyzed.
Secondary
Target Lesion Revascularization Rate
To examine, describe and compare/contrast within and between Drug Coated Balloon groups. 1. Target lesion revascularization rate 2. Safety event rate 3. Healthcare utilization costs
Time frame: 12 months
Population: Data were not collected.~Insufficient number of participants enrolled to perform data analysis prior to study closure.