Advertisement

August 19, 2019

Vascular Therapies Completes Enrollment in the Phase 3 ACCESS Trial

August 19, 2019—Vascular Therapies, Inc. announced the completion of enrollment for the ACCESS trial. The phase 3 prospective, randomized, multicenter, clinical study is being conducted in the United States to evaluate the effectiveness of the company's sirolimus drug product to improve outcomes in patients undergoing surgical creation of an arteriovenous fistula to provide vascular access for hemodialysis in patients with kidney disease.

The company is developing its sirolimus formulation for intraoperative local, perivascular drug delivery. The goal of this therapeutic approach is to improve vascular surgery outcomes in patients with kidney and vascular diseases. The phase 3 randomized clinical trial evaluating this investigational therapy is being performed under a Special Protocol Assessment (SPA). The drug development program has received Fast Track status from the FDA and sirolimus has an orphan-drug designation for the dialysis vascular access indications in the United States and European Union.

According to Vascular Therapies, the ACCESS study enrolled 269 patients across 20 centers in the United States. The phase 3 trial design included an open-label subset—the first patient enrolled by a surgeon, definitely received the sirolimus drug product. The primary endpoint of the study is "fistula suitability for dialysis" at 6 months and results are expected to be announced in the second quarter of 2020.

Advertisement


August 19, 2019

Five-Year Data Published for ENGAGE Global Registry of Medtronic's Endurant EVAR Device

August 16, 2019

Three-Year Outcomes Presented From CSI's LIBERTY 360° Postmarket Study