Lutonix or Inpact for tHE tReatment Of fEmeropopliteal Stenosis - DCB

Peripheral Arterial Disease Clinical Trial

— HEROES-DCB  

Official title:

Lutonix or Inpact for tHE tReatment Of fEmeropopliteal Stenosis - DCB

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02812966
• Other study ID #: C5000163
• Status: Recruiting
• Phase: N/A
• First received: June 21, 2016
• Last updated: March 22, 2017
• Start date: April 2016
• Est. completion date: April 2019

Study information

• Verified date: March 2017
• Source: Advocate Health Care
• Contact: Chris Doherty, RN
• Phone: (708) 684-4618
• Email: christopher.doherty[@]advocatehealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 PTA Catheter and IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter.

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 PSVR <=2.4 at 12month follow-up visit with no TLR or target lesion bypass) between the subjects with Lutonix 035 Drug coated Balloon PTA Catheter and IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter. Investigators will also assess and compare target lesion revascularization rates, safety profiles, adverse events, healthcare costs, and healthcare utilization.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

• 4-7mm vessel diameter

• <=15cm 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 DCB

3. < 18 years of age at time of consent and/or index procedure

4. Pregnant or Breast feeding

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 SFA/PPA in the target limb to treat atherosclerotic disease.

13. Use of atherectomy, laser or other debulking devices in the target limb SFA/PPA during the index procedure.

14. Acute ischemia and/or acute thrombosis of the SFA/PPA 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 (MI) or cerebrovascular accident (CVA) <=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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Lutonix
Drug Coated Balloons
• IN.PACT
Drug Coated Balloons

Locations

Country	Name	City	State
United States	Advocate Illinois Masonic Medical Center	Chicago	Illinois
United States	Advocate Good Samaritan Hospital	Downers Grove	Illinois
United States	Advocate South Suburban Hospital	Hazel Crest	Illinois
United States	Edward Hospital	Naperville	Illinois
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Prairie Education and Research Collaborative	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Advocate Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	12 months
Secondary	Target lesion revascularization rate		12 months