NCT02013193: RANGER-SFA

Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries

Completed NA Last updated 23 December 2019

What this trial tests

NA trial testing Ranger DCB in Peripheral Artery Disease in 105 participants. Completed in 15 March 2019.

Timeline

7 January 2014

Primary endpoint
16 June 2016

15 March 2019

Quick facts

Lead sponsor	Hemoteq AG
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	105
Start date	7 January 2014
Primary completion	16 June 2016
Estimated completion	15 March 2019
Sites	11 locations across Austria, France, Germany

Drugs / interventions tested

• Ranger DCB
• uncoated PTA balloon

Conditions studied

• Peripheral Artery Disease — all drugs for Peripheral Artery Disease →
• Claudication — all drugs for Claudication →
• Atherosclerosis — all drugs for Atherosclerosis →
• Arteriosclerosis — all drugs for Arteriosclerosis →

Sponsor

Hemoteq AG

Who can join

18 and older, any sex, with Peripheral Artery Disease or Claudication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of this study is to prove the superior performance of the Ranger™ paclitaxel-coated PTA balloon catheter for angioplasty for femoropopliteal artery lesions when compared to non-coated balloons at six months post-procedure when comparing Late Lumen Loss (LLL). Study statistical hypothesis: The %-mean loss of luminal diameter as assessed by angiography at six months follow-up after treatment of the femoropopliteal artery with Ranger DCB study devices is lower than the %-mean loss of luminal diameter after treatment with uncoated PTA balloon control devices.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
   Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, et al · · 2018 · cited 602× · PMID 30561254 · DOI 10.1161/jaha.118.011245
2. 12-Month Results From the First-in-Human Randomized Study of the Ranger Paclitaxel-Coated Balloon for Femoropopliteal Treatment.
   Steiner S, Willfort-Ehringer A, Sievert H, Geist V, et al · · 2018 · cited 64× · PMID 29730375 · DOI 10.1016/j.jcin.2018.01.276
3. Six-Month Results From the Initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment.
   Bausback Y, Willfort-Ehringer A, Sievert H, Geist V, et al · · 2017 · cited 38× · PMID 28558502 · DOI 10.1177/1526602817710770
4. Endovascular revascularization strategies for aortoiliac and femoropopliteal artery disease: a meta-analysis.
   Koeckerling D, Raguindin PF, Kastrati L, Bernhard S, et al · · 2023 · cited 37× · PMID 36721954 · DOI 10.1093/eurheartj/ehac722
5. Safety of paclitaxel-coated devices in the femoropopliteal arteries: A systematic review and meta-analysis.
   Zhang C, Yin G. · · 2022 · cited 6× · PMID 36227807 · DOI 10.1371/journal.pone.0275888
6. Data sources and applied methods for paclitaxel safety signal discernment.
   Gressler LE, Avila-Tang E, Mao J, Avalos-Pacheco A, et al · · 2023 · cited 1× · PMID 38463423 · DOI 10.3389/fcvm.2023.1331142