CLINICAL OUTCOMES ARE PROVIDING PROMISING RESULTS

In addition to the current Phase 3 study, Vascular Therapies has completed three clinical studies evaluating the safety, feasibility, and performance of the Sirolimus‑eluting Collagen Implant in hemodialysis fistulas (arteriovenous fistulae and arteriovenous grafts) and above knee peripheral bypass graft surgery. Clinical outcomes using the Sirolimus‑eluting Collagen Implant have provided promising results.

The Current Phase 3 Study

The ACCESS Study is a Phase 3 randomized, single blind, multicenter study designed to evaluate the efficacy and safety of the Sirolimus eluting Collagen Implant in subjects undergoing surgery for creation of a new hemodialysis fistula. Preliminary results suggest this investigational treatment approach may reduce a patient’s dependence on the extended use of catheters – the way most patients begin dialysis treatment.

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COMPLETED CLINICAL STUDIES

Time from hemodialysis fistula creation

Vascular Therapies has completed a prospective, multi‑center non-randomized, single-arm study to evaluate the performance of the Sirolimus-eluting Collagen Implant in patients undergoing surgical creation of an AV fistula. All enrolled subjects were on hemodialysis and required the creation of a permanent vascular access at the time of inclusion in the study. The drug product was tested in 30 patients; 22 subjects received a radiocephalic fistula at the wrist and 8 subjects received a brachiocephalic fistula near the elbow.

There were no significant side effects attributable to the Sirolimus Drug product. Study results demonstrated improvement in key measures of fistula function, compared to current standard of care outcomes. Specifically:

  • 87% hemodialysis fistula maturation rate (by KDOQI criteria)
  • Mean time to maturation of 4 weeks
  • 87% fistulae successfully cannulated for dialysis
  • Mean time to first cannulation of 7 weeks
  • Primary unassisted patency at 6 months was 76%
  • Primary unassisted patency at 12 months was 74%

Study outcomes support safety, feasibility and provide a strong efficacy signal. The prophylactic treatment of the anastomosis and the juxta-anastomotic segment of an AV fistula with sirolimus delivered locally to vascular wall may

  1. Improve the proportion of AV fistulae that mature into a useful conduit for dialysis
  2. Reduce time to first cannulation, and,
  3. Improve the unassisted suitability of arteriovenous fistulae for dialysis (preserved functionality at 6 months and 12 months)

Devita et al. Improved Arteriovenous Fistula Maturation with Intra-Operative Implant of a Perianastomotic Sirolimus Eluting Collagen Membrane (Coll-R). 2011 American Society of Nephrology Annual Meeting (abstract and oral presentation). J Am Soc Nephrol 2011; 22: 110A.

Vial and tweezers

Historically, AV grafts have poor primary patency rates ranging between 25‑50% at one year. The primary failure mode, graft thrombosis results from an aggressive neointimal tissue response causing a flow limiting stenosis at the graft venous anastomosis.

Vascular Therapies has completed a prospective, single‑center non-randomized, single-arm study to evaluate the performance of the Sirolimus-eluting Collagen Implant in 12 patients undergoing surgical creation of an AV graft. There were no significant side effects attributable to the Sirolimus Drug product. Study results demonstrated improvement in key measures of AV graft function, compared to current standard of care outcomes. Specifically, primary unassisted graft patency was 82% at 6 months and 73% at one year.

Paulson et al. Safety and efficacy of local periadventitial delivery of sirolimus for improving hemodialysis graft patency: first human experience with a sirolimus-eluting collagen membrane (Coll-R). Nephrology Dialysis Transplantation. 2012 Mar;27(3):1219–24.

Chart recorder high angle

For over 60 years bypass grafting has proven to be an effective form of treatment for occlusive peripheral arterial disease. However, due to the lack of an effective treatment option, there is a major, important and as yet unresolved issue – anastomotic site neointimal hyperplasia – an important factor contributing to the failure of bypass grafts. A treatment solution that will increase the durability of bypass grafts is a high clinical priority because it defines a huge unmet clinical need.

Vascular Therapies has completed a prospective, single‑center non-randomized, single-arm study to evaluate the performance of the Sirolimus-eluting Collagen Implant in 10 patients with PAD undergoing peripheral arterial (above-knee femoropopliteal) bypass graft surgery.

There were no significant side effects attributable to the Sirolimus Drug product. Study results demonstrated improvement in key measures of graft utility compared to current standard of care outcomes. Specifically, primary unassisted graft patency was 90% at 6 months, 88% at one year, and 63% at two years.

Caution: The Sirolimus-eluting Collagen Implant is an investigational product that is not available for sale in any country.
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