MedAlliance has announced enrolment of the first two patients in the PRISTINE registry with Selution sustained limus release (SLR) 018 drug-eluting balloon (DEB) for the treatment of patients with below-the-knee disease. This is the first DEB accepted by the US Food and Drug Administration (FDA) for its breakthrough programme.
The PRISTINE registry is a follow up to the encouraging results seen in the PRESTIGE clinical trial (below the knee, chronic limb threatening ischaemia [CLTI]) at six months.
PRISTINE is a prospective registry to investigate the safety and efficacy of treatment with Selution SLR sirolimus drug-coated balloon in TASC C and D athero-occlusive infrainguinal disease in patients with CLTI from Singapore.
The objective of the registry is to evaluate over 12 months safety and performance outcomes in 75 patients, with Selution SLR DEB in the treatment of infrainguinal occlusive lesions (TASC C and D) in patients with CLTI at Singapore General Hospital.
The clinical primary safety endpoint of the registry is freedom from major adverse events through 30 days and the performance primary endpoint is freedom from cd-TLR within six months. The secondary endpoints are primary patency at six and 12 months follow-up, freedom from cd-TLR at 12 months, clinical success at follow-up in Rutherford score by one class or more, wound healing at six months, and freedom from major target limb amputation within six and 12 months post index procedure.
“We are excited about the commencement of this large single-centre prospective study focusing on patients with chronic limb threatening ischemia receiving the novel sirolimus drug-eluting balloon (Selution SLR DEB) from MedAlliance”, said associate professor Chong Tze Tec, head and senior consultant, Department of Vascular Surgery, Singapore General Hospital. “We believe this registry will give us detailed insight into the efficacy and safety of this new balloon technology which will benefit this challenging group of patients.”
“We are delighted to report enrolment of the first two patients in the exciting PRISTINE registry”, added associate professor Tjun Tang, lead Investigator and a senior consultant in the Department of Vascular Surgery, Singapore General Hospital. “CLTI represents the worse part of the spectrum of peripheral artery disease and patients are at an increased risk of limb loss and mortality. The incidence is likely to increase in Singapore because of the rising trend in diabetes and end stage renal disease in the country and these patients are a challenging and frail population of patients.
“We currently do far too many major lower limb amputations: in fact the rate in Singapore is two to three times higher than in western countries. We seriously need to address this issue. One of the cornerstones of treatment is to re-establish pulsatile blood flow to the foot to promote wound healing and although percutaneous lower limb angioplasty has become the favoured option of revascularization, its Achilles heel is vessel recoil and restenosis from neointimal hyperplasia”.
“Singapore General Hospital performs over 900 lower limb salvage revascularisation procedures per year and has established multi-disciplinary wound management protocols and we are highly encouraged by the pilot data we have found using this technology so far and PRISTINE will offer further insight, leveraging on our experience with PRESTIGE, whether this sirolimus coated balloon will become an established device in our angioplasty armamentarium in the future”, concluded Tang.