Overview

This trial is active, not recruiting.

Conditions femoral artery occlusion, femoral arterial stenosis
Treatment lutonix paclitaxel drug coated balloon
Sponsor C. R. Bard
Start date December 2013
End date March 2018
Trial size 150 participants
Trial identifier NCT02013271, CL0017-01

Summary

To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Lutonix Paclitaxel Drug Coated Balloon
lutonix paclitaxel drug coated balloon

Primary Outcomes

Measure
Safety: Composite of freedom from all-cause periprocedural death and freedom at 1 year from the following: index limb amputation (above or below the ankle) and index limb re-intervention.
time frame: 30 Days
Efficacy: Primary Patency
time frame: 12 Months

Secondary Outcomes

Measure
Safety: Major vascular complications (≤30 day)
time frame: 1, 6, 12, 24, 36 months
Efficacy: Acute Device, Technical and Procedural success
time frame: 6, 12 and 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Clinical Criteria 1. ≥ 18 years of age; 2. Rutherford Clinical Category 2-4; 3. Subject is legally competent and voluntarily agrees to participation and the study's provisions; is willing to provide 5-year informed consent; 4. ≥ 70% stenosis of a native femoropopliteal artery (by visual estimate) that is amenable to DCB with or without stenting; 5. TASC II Class C or D Lesions with intended target lesion treatment segment(s) cumulatively ≥14 cm in length; 6. de novo lesion(s) or non-stented restenotic lesion(s) > 90 days from prior angioplasty procedure; 7. Target vessel diameter between ≥ 4 and ≤ 7 mm; 8. Successful wire crossing of lesion and predilatation; 9. No other prior vascular interventions (including contralateral limb) within 2 weeks before and/or planned 30 days after the protocol treatment. Exclusion Criteria: 1. Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children; 2. Patient is contraindicated to use Lutonix Drug Coated Balloon per the current Instructions For Use (IFU); 3. Life expectancy of < 1year; 4. Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; 5. History of stroke within 3 months; 6. History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment; 7. Prior vascular surgery of index limb with exception of endarterectomy or remote common femoral patch angioplasty; 8. Target lesion involves a previously placed stent; 9. Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication; 10. Significant inflow disease; 11. Known inadequate distal outflow or planned future treatment of vascular disease; 12. Sudden symptom onset, acute vessel occlusion, or acute or sub-acute angiographically visible thrombus in target vessel; 13. Use of adjunctive treatment modalities (e.g. laser, atherectomy or cryoplasty)

Additional Information

Official title A Prospective, Multicenter, Single-Arm Trial With the Lutonix Drug Coated Balloon for Treatment of Long Lesions in Femoropopliteal Arteries
Principal investigator Martin Banyai, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by C. R. Bard.