28. February 2022

Qmedics is proud to announce the first Enrolment in the “HORIZON” trial for the Treatment of PAD

Specific focus on the SFA and P1 – with the EXIST self-expandable “PULL” and FLEX” Stent System types. (See the full case film in the clinical studies Rubric)

The Horizon study will provide information on the long-term outcomes of the innovative EXIST NiTi self- expandable stent with its two types of PULL & FLEX, designed to be used in combination with the new Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter MANATEE. The EXIST NiTi stent is specifically tailored for, but not only limited to the treatment of the femoropopliteal region taking into account the patient’s anatomy and lesion characteristics.

Self-expandable nitinol stenting can accomplish revascularization of severely diseased peripheral arteries with good clinical success and freedom from complications. However, longer-term patency rates in the femoro-popliteal region remain a concern, especially due to the extrinsic forces of flexion and torsion acting on these arteries with the movements of the lower limbs. At this level, heavy calcifications and lesions that are present in the distal Superficial Femoral Artery (SFA) and the P1 tract of the Popliteal Artery represent the main technical challenges and require stents with dedicated structural characteristics. The aim of the Horizon study is to test, in the femoro-popliteal,region  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.

The HORIZON trial is a prospective, non-randomized, multi-centre, multi-national, open-label, post-market clinical trial conducted in several investigational sites in Europe. The target population is subjects with a documented diagnosis of Peripheral Artery Disease (PAD) requiring Percutaneous Transluminal Angioplasty (PTA) treatment and stent placement at the Superficial Femoral Artery (SFA) or Proximal Popliteal Artery (P1 segment). Subjects, who meet all inclusion and none of the exclusion criteria will be treated with the Qmedics EXIST NiTi Stent type FLEX and/or PULL. Subjects requiring treatment of the P1 segment of the proximal popliteal artery will be treated with the Qmedics EXIST NiTi stent type FLEX. Subjects  requiring  treatment  of  the  SFA  will  undergo  an  additional  calcification  review  based  on  the Fanelli  classification. Subjects graded with Fanelli 1 or 2 will be treated with the Qmedics EXIST NiTi Stent FLEX. Fanelli grade 3 and 4 subjects will be treated with the Qmedics EXIST NiTi Stent PULL. There will be 230 subjects enrolled in HORIZON and the trial will be conducted in several investigational centres in Europe.

This new generation of Qmedics NiTi stent family is a self-expanding nitinol stent system made in 3 variants (4, 5 and 6F NiTi Stent System), two types – PULL and FLEX – and with stent lengths in both types ranging up to 200mm. The portfolio was launched in the EU and other CE mark-accepting countries in the very difficult year of 2020, where COVID was playing an inhibitory role but Qmedics did succeed, nonetheless. Now with the help of the professionals, we will gather the clinical evidence on this innovative concept.

The first patient was enrolled by investigator Prof. Dr. Hab. n. med. Jerzy Głowiński and Dr.M Chlabicz Vascular Surgeons at University Clinical Hospital of Bialystok, Poland.

Prof. Dr. Hab. n. med. Jerzy Głowiński added, “These products provide new treatment opportunities, including the opportunity to perform cases using radial access, thanks to the long usable length catheters, the low-profile design, and the thin-strut stent design.

“When I first heard about this new approach “a stent design that is in compliance with the movability of the artery and the characteristics of the lesion, I was wondering. Now that we used the Qmedics stent systems, we are convinced the clinical evidence will show the benefits” added Dr. M Chlabicz.

The Second investigator Prof. Dr. med. Pierfrancesco Veroux, who is including patients at University Hospital of Catania, Italy added “I am enthusiastic to collect  clinical data on this new concept of a peripheral  stent system. Finally, we got some engineers who achieved to design a stent system that combines different radial forces with the movability characteristics of the arteries- I find this to be very interesting.“

Prof. Dr. Enrico Maria Marone at the Policlinico di Monza, Italy added : “Finally we have two different stents for different anatomies and lesions rather than one stent that fits all”.

Dr .Med. Frédéric Glauzer  – Hôpital Universitaires de Genève is waiting for the ethical committee approval , then also he and his team will start the enrollment .Dr Glauzer did already used the Qmedics EXIST stent system and was positively surprised of the behavior of the stent system

Dr. Adriaan Moelker – Erasmus University hospital Rotterdam is waiting for the ethical committee approval , then also he and his team will start the enrollment