deltatrials
Completed NA INTERVENTIONAL 2-arm NCT02063672

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

Updated 15 times since 2017 Last updated: Mar 28, 2019 Started: Mar 31, 2014 Primary completion: Feb 13, 2017 Completion: Mar 31, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Jun 2018 · 13 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Nov 2018 · 2 months · monthly snapshot~Nov 2018 – ~Jan 2019 · 2 months · monthly snapshot~Jan 2019 – ~Mar 2019 · 59 days · monthly snapshot~Mar 2019 – ~May 2019 · 2 months · monthly snapshot~May 2019 – ~Jan 2021 · 20 months · monthly snapshot~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

15 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed NA

  2. Sep 2024 — Sep 2025 [monthly]

    Completed NA

  3. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  4. Jan 2021 — Jul 2024 [monthly]

    Completed NA

  5. May 2019 — Jan 2021 [monthly]

    Completed NA

    Status: Active Not RecruitingCompleted

Show 10 earlier versions
  1. Mar 2019 — May 2019 [monthly]

    Active Not Recruiting NA

  2. Jan 2019 — Mar 2019 [monthly]

    Active Not Recruiting NA

  3. Nov 2018 — Jan 2019 [monthly]

    Active Not Recruiting NA

  4. Sep 2018 — Nov 2018 [monthly]

    Active Not Recruiting NA

  5. Aug 2018 — Sep 2018 [monthly]

    Active Not Recruiting NA

  6. Jul 2018 — Aug 2018 [monthly]

    Active Not Recruiting NA

  7. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting NA

  8. May 2017 — Jun 2018 [monthly]

    Active Not Recruiting NA

    Phase: PHASE3NA

  9. Feb 2017 — May 2017 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  10. 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

Sponsor contact:
  • C. R. Bard
Data source: C. R. Bard

For direct contact, visit the study record on ClinicalTrials.gov .