Completed NA INTERVENTIONAL 2-arm NCT02540018

Effectiveness of Paclitaxel-coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Arteria Femoralis Superficialis (EffPac)

Multicenter Randomized Controlled Trial to Assess the Effectiveness of Paclitaxel-coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral and Popliteal Arteries to Prevent Vessel Restenosis or Reocclusion

Sponsor: Jena University Hospital

Conditions Peripheral Arterial Disease

Interventions Transluminal Angioplasty with Paclitaxel-coated Luminor® Balloon Catheter in the Superficial Femoral and Popliteal Arteries Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheter

Updated 11 times since 2017 Last updated: Mar 10, 2023 Started: Sep 15, 2015 Primary completion: Dec 31, 2016 Completion: Jan 14, 2022

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02540018, this NA trial focuses on Peripheral Arterial Disease and remains completed. Sponsored by Jena University Hospital, it has been updated 11 times since 2015, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

11 versions recorded

Sep 2024 — Present [monthly]

Completed NA
Jul 2024 — Sep 2024 [monthly]

Completed NA
Apr 2023 — Jul 2024 [monthly]

Completed NA

Status: Active Not Recruiting → Completed
Nov 2022 — Apr 2023 [monthly]

Active Not Recruiting NA
Oct 2021 — Nov 2022 [monthly]

Active Not Recruiting NA

▶ Show 6 earlier versions

Jan 2021 — Oct 2021 [monthly]

Active Not Recruiting NA
May 2020 — Jan 2021 [monthly]

Active Not Recruiting NA

Status: Unknown Status → Active Not Recruiting
Jun 2019 — May 2020 [monthly]

Unknown Status NA

Status: Active Not Recruiting → Unknown Status
Jun 2018 — Jun 2019 [monthly]

Active Not Recruiting NA
Jun 2017 — Jun 2018 [monthly]

Active Not Recruiting NA

Status: Recruiting → Active Not Recruiting · Phase: PHASE4 → NA
Jan 2017 — Jun 2017 [monthly]

Recruiting PHASE4

First recorded

Sep 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Jena University Hospital
KKS Netzwerk
iVascular S.L.U.

Data source: Jena University Hospital

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

Study Locations

Arnsberg, Germany , Bad Krozingen, Germany , Berlin, Germany , Hamburg, Germany , Heidelberg, Germany , Jena, Germany , Karlsbad-Langensteinbach, Germany , Kusel, Germany , Leipzig, Germany , München, Germany and 1 more location