Enrolment of the first patients in the BELONG study—benefit of arterial vessel preparation by arterial by longitudinal micro-incisions before drug-eluting balloon angioplasty of the superficial femoral and popliteal arteries—has been announced by VentureMed Group.
The primary objective of this clinical study is to evaluate lumen patency at 12 months obtained by preparation of vessels with the FLEX vessel preparation system prior to conventional endovascular recanalization of the superficial and popliteal arteries. According to a press release, the FLEX system creates long parallel, linear micro-incisions in all plaque morphologies to prepare an ideal vessel environment to facilitate drug-coated balloon angioplasty. The dynamic micro-incision technique of the FLEX system safely facilitates the treatment of difficult, diseased vessels, improving vessel compliance and acute lumen gain.
This prospective, single arm, non-randomised study will enrol up to 150 patients in Switzerland. Patients will exit from the study at the completion of their twelve-month follow-up. The primary investigator and co-investigator are Daniel Périard and Rolf Engleberger (both HFR- Hôpital Cantonal Fribourg, Villars-sur-Glâne, Switzerland).
“We believe preparing arterial vessels by delivering parallel longitudinal micro-incisions with the FLEX system prior to drug-coated balloon angioplasty has the potential to demonstrate long-term clinical benefits for patients. Our early results have shown that arterial vessel preparation with the FLEX system resulted in improved lumen expansion and vessel compliance after drug-coated balloon angioplasty, with a corresponding reduction in the rate of dissection,” says Périard.
Daniel Hayoz, head of the medical clinic at HFR- Hôpital Cantonal Fribourg, Villars-sur-Glâne, Switzerland, introduced the BELONG study at the 45th VEITH annual symposium (13-17th November 2018, New York, USA) in a presentation titled “Arterial preparation improves outcomes of drug-coated balloon angioplasty.” A poster outlining the concept and inclusion status of the BELONG study won Best Poster at the 2018 Union of Vascular Societies of Switzerland (UVSS) meeting in Lugano, Switzerland (24–26 October, 2018).
Périard will be presenting the recruitment status and early results of the BELONG study at the Leipzig Interventional Course (LINC) on 22 January 2019 in Leipzig, Germany.