Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis (SFA ISR)
A Prospective, Multicenter, Single-Blind, Randomized, Controlled Trial Comparing the Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
Sponsor: C. R. Bard
Listed as NCT02063672, this NA trial focuses on Femoral Artery Occlusion and Femoral Artery Stenosis and remains completed. Sponsored by C. R. Bard, it has been updated 15 times since 2014, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
15 versions recorded-
Sep 2025 — Present [monthly]
Completed NA
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Sep 2024 — Sep 2025 [monthly]
Completed NA
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Jul 2024 — Sep 2024 [monthly]
Completed NA
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Jan 2021 — Jul 2024 [monthly]
Completed NA
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May 2019 — Jan 2021 [monthly]
Completed NA
Status: Active Not Recruiting → Completed
▶ Show 10 earlier versions
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Mar 2019 — May 2019 [monthly]
Active Not Recruiting NA
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Jan 2019 — Mar 2019 [monthly]
Active Not Recruiting NA
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Nov 2018 — Jan 2019 [monthly]
Active Not Recruiting NA
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Sep 2018 — Nov 2018 [monthly]
Active Not Recruiting NA
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Aug 2018 — Sep 2018 [monthly]
Active Not Recruiting NA
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Jul 2018 — Aug 2018 [monthly]
Active Not Recruiting NA
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Jun 2018 — Jul 2018 [monthly]
Active Not Recruiting NA
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May 2017 — Jun 2018 [monthly]
Active Not Recruiting NA
Phase: PHASE3 → NA
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Feb 2017 — May 2017 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE3
First recorded
Mar 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- C. R. Bard
For direct contact, visit the study record on ClinicalTrials.gov .