Lutonix or Inpact for tHE tReatment Of fEmeropopliteal Stenosis - Drug Coated Balloon

NCT02812966 | Terminated Results

• 1 other identifier: C5000163
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 6

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.

Conditions

Peripheral Arterial Disease

Keywords

peripheral arterial disease; drug coated balloon

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (1)

• Target Lesion Revascularization Rate

  12 months

Study Arms (2)

Lutonix Drug Coated Balloon

ACTIVE COMPARATOR

Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter

Device: Lutonix

IN.PACT Drug Coated Balloon

ACTIVE COMPARATOR

IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

Device: IN.PACT

Interventions

Lutonix DEVICE

Drug Coated Balloons

Lutonix Drug Coated Balloon

IN.PACT DEVICE

Drug Coated Balloons

IN.PACT Drug Coated Balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Male or non-pregnant female
• Age greater \>=18 years of age
• Patients with moderate to severe claudication or ischemic rest pain as defined by Rutherford 2-4 class symptoms
• \>=1 tibial run-off vessel at baseline
• Angiographic criteria
• \>=70% stenosis (via visual angiographic estimate in the superficial femoral artery and/or popliteal arteries as appropriate)
• 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.

You may not qualify if:

• Unable to meet clinical criteria to have peripheral angioplasty and follow-up treatment (lab values and pregnancy test)
• Contra-indicated to either drug coated balloon
• \< 18 years of age at time of consent and/or index procedure
• Pregnant or breastfeeding
• In-stent restenosis within the target lesion
• Previously stented target lesion/vessel.
• Target lesion/vessel previously treated with drug-coated balloon \<12 months prior to randomization/enrollment.
• Perforated vessel as evidenced by extravasation of contrast media prior to consent or enrollment.
• Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention \<=30 days of consent or randomization.
• Presence of aneurysm in the target vessel.
• Major amputation in the target limb.
• Subjects who have undergone prior surgery of the superficial femoral artery/proximal popliteal artery in the target limb to treat atherosclerotic disease.
• Use of atherectomy, laser or other debulking devices in the target limb superficial femoral artery/proximal popliteal artery during the index procedure.
• Acute ischemia and/or acute thrombosis of the superficial femoral artery/proximal popliteal artery prior to consent or randomization.
• Known hypersensitivity or contraindication to contrast dye that, in the opinion of the local investigator, cannot be adequately pre-medicated.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (6)

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States

Location

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515, United States

Location

Advocate South Suburban Hospital

Hazel Crest, Illinois, 60429, United States

Location

Edward Hospital

Naperville, Illinois, 60540, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Prairie Education and Research Collaborative

Springfield, Illinois, 62701, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Director, Clinical Trials Research Cardiovascular and Multiple Specialties
• Organization: Advocate Aurora Research Institute

laura.wrona@aah.org

708-860-7792

Study Officials

• Jaafer Golzar, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 24, 2016
• Study Start: April 1, 2016
• Primary Completion: December 2, 2019
• Study Completion: December 2, 2019
• Last Updated: October 8, 2024
• Results First Posted: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)