31. May 2022
First public announcement of the Horizon trial , were Qmedics “back to the basics concept” with the innovative stent design that takes into account both movability and lesion characteristics.
With a portfolio consisting of three variances 4,5&6 French and two types PULL & FLEX - at the Linc congress in Leipzig. Tuesday, 7 June 2022 Room 3 Speakers corner : Latest results from clinical trials and innovations
Treatment of the Femoro-Popliteal district with the innovative Exist NiTi Stent (QMEDICS) type Flex & Pull: the HORIZON clinical trial.
Marone E.M.1, Rinaldi L.F.2, Brioschi C.3, Glowinski J.4, Chlabicz M.5,Veroux P.6 ,Moelker A.7,Glauser F.8
- University of Pavia, Department of Vascular Surgery, Policlinico di Monza, Monza, Italy
- Medical University of Bialystock, University Clinical Hospital of Bialystok, Department of Vascular Surgery and Transplantation Bialystok, Poland
- University of Catania, University Hospital of Catania G. Rodolico -San Marco, Department of vascular surgery Catania, Italy
- University Erasmus MC, Rotterdam, University Medical center, Department of Radiology and Nuclear Medicine, Rotterdam, The Netherlands
- University of Genova, Geneva University Hospitals, Department of Vascular Surgery, Genève, Switzerland
Aim: Self-expandable nitinol stenting can accomplish revascularization of severely diseased peripheral arteries with good clinical success and freedom from complications1. However, longer-terms patency rates in the femoro-popliteal district is still a concern, especially due to the extrinsic forces of flexion and torsion acting on these arteries with the movements of the lower limb2. At this level, heavy calcifications and lesions involving the distal superficial femoral artery (SFA) and the tract P1 of the popliteal artery represent the main technical challenges and require stents with dedicated structural characteristics 3,4.
The aim of the Horizon study is to test on the femoro-popliteal district the two types of Exist NiTi Stent (Flex and Pull), whose design is. meant to comply with the movability of the SFA and P1, while adapting to the specific characteristics of difficult atherosclerotic plaques.
Materials and methods: The NiTi stent family is a self-expanding nitinol stent system made in 3 variants (4, 5 and 6F NiTi Stent System) and two types; PULL and FLEX. The PULL variant has a higher radial force and is meant for the treatment of difficult to reach, severely calcified lesions, thanks to its longitudinal movability. The FLEX variant has a high bending movability and it is indicated for moderately calcified and distal lesions. These devices have proved safety and effectiveness in large set investigations, but the overall rationale for this investigation is to provide long term outcomes and collect additional data including health economics data.
The Horizon study is a multicenter, prospective non-randomized clinical trial enrolling 250 patients affected by peripheral artery disease involving the SFA or P1 (TASC II A-B-C) and candidate to stenting with the Exist NiTi Stent in 5 European Centers. The choice of Pull or Flex type is based on the lesion characteristics: subjects requiring treatment of P1 are treated with
type Flex. Subjects requiring treatment of the SFA undergo an additional calcification review based on the Fanelli classification5. Subjects graded with Fanelli 1 or 2 are treated
with the Flex Stent. Fanelli grade 3 and 4 subjects receive the type Pull Stent. After implantation, clinical and instrumental follow-up after 6, 12 and 24 months will assess success and outcome durability. Follow-up evaluation includes Rutherford/Fontaine Categorization, ABI, Walking Impairment- and Quality of Life questionnaire, and DUS imaging,
Results: Primary endpoints are freedom from perioperative adverse events and 12-months patency rate. Secondary endpoints include 6- and 12-months clinical success and technical success at 12 and 24 months. The criterion for success of the trial is defined by the primary endpoint, with a patency rate threshold of 50% after 12 months.
Conclusion: Stenting of the femoro-popliteal district poses important technical challenges related to high artery movability and complex, calcified lesions. The Horizon study will provide long-term outcomes of the innovative Exist NiTi stent with the two types PULL & FLEX which allows for treatment of the SFA and P1 tailored on the patient’s anatomy and lesion characteristics.
- Das T. et al. Optimal therapeutic approaches to femoropopliteal artery intervention." Catheter Cardio Interven 2004; 63(1): 21-30.
- Laird JR. et al. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: Twelve month results from the RESILIENT randomized trial. Circulation: Cardiovascular Interventions 2010;3(3): 267-276.
- Erwin PA. et al Contemporary management of femoral popliteal revascularization. Intervent Cardiol Clinics 2014;3(4):517-530.
- Maleckis K. et al. Nitinol Stents in the femoropopliteal artery: A mechanical perspective on material, design, and performance. Ann Biomed Eng. 2018;46(5): 684–704.
- Fanelli, F. et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol. 2014;37:898–907.