EICHOR
● Active Not Recruiting
A Trial to Evaluate the Safety and Efficacy of the Passeo-18 Lux Drug-coated Balloon of Biotronik in the Treatment of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral Drug-coated Balloon.
Condition: Peripheral Arterial Disease · Sponsor: KANDO Research
About this study
The BIOPACT RCT tiral investigates the efficacy and safety of stenosis, restenosis or occlusions in the femoropopliteal artery of patients presenting a rutherford classification 2,3 or 4 with a Passeo-18 Lux drug-coated balloon of Biotronik. The Paclitaxel eluting balloons are designed for percutaneous transluminal angioplasties in which the balloon will dilate the artery upon inflation and deliver the paclitaxel locally. An expected total of 151 patients will be treated with the Passeo-18 Lux and compared to a control group of another 151 patients that will be treated with the IN.PACT Admiral drug-coated balloon of Medtronic. Assignment to the treatment groups will be at random. The study will be conducted in two phases. A first pilot study phase of 120 patients distributed evenly over both treatment groups and a second phase to formally test the non-inferiority hypothesis. The balloon is coated with Paclitaxel intended to avoid cellular proliferation. The drug is released by means of rapid inflation as to release a high dose in a short amount of time. Patients will be invited for a follow-up visit at 1, 6 and 12 months post-procedure. The primary efficacy endpoints are defined as follows. Freedom from clinically-driven target lesion revascularization at 12 months. Freedom from device- and procedure-related death through 30 days post-index procedure, major target limb amputation through 12 months post-procedure and clinically-driven target vessel revascularization through…
This description comes directly from the study's public registry record.
Talk to the study team
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Locations (14)
| Medical University of Graz | Graz, Graz, Austria | — |
| Hanusch Hospital | Vienna, State of Vienna, Austria | — |
| UZA | Antwerp, Antwerp, Belgium | — |
| OLV Ziekenhuis Aalst | Aalst, Oost-Vlaanderen, Belgium | — |
| Imelda Hospital | Bonheiden, Belgium | — |
| A.Z. Sint-Blasius | Dendermonde, Belgium | — |
| Z.O.L. | Genk, Belgium | — |
| R.Z. Heilig Hart | Tienen, Belgium | — |
| CHU Bordeaux | Bordeaux, New Aquitaine, France | — |
| Clinique Pasteur | Toulouse, Occitanie, France | — |
| Clinique Rhône Durance | Avignon, Provence-Alpes-Côte d'Azur Region, France | — |
| Hopital Paris Saint Joseph | Paris, France | — |
+ 2 more locations — full list on the registry record.
Follow this study
Save your interest here for when the public record changes — results posted, or the study's status changes. Email alerts for this study aren't switched on yet.
We keep this only about this public record, and never email you without alerts being switched on. Want it removed at any time? Email hello@eichor.com. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT03884257