DEPENDABLE SOLUTIONS
FOR COMPLEX CASES

Clinical Evidence RESTOR-1 Study1

AngioSafe’s Atheroplasty™ platform is backed by rigorous clinical evaluation. Designed to enable safe, efficient, and wire-free crossing of complex CTOs.

RESTOR-1 Pivotal Trial:

A prospective, multi center, pivotal study, conducted at 14 sites in the United States with 74 patients enrolled, treated, and core lab adjudicated.

Objective:

To demonstrate the safety and effectiveness of the Santreva™-ATK System to facilitate crossing of CTOs in the peripheral vasculature.

Key Inclusion Criteria:

  • Rutherford Classification Criteria 2-5
  • Femoropopliteal arteries
  • 99-100% stenosed
  • Max 300mm long, regardless of calcium severity

Primary Endpoint:

Clinical success of Santreva-ATK to facilitate placement of guidewire into the distal true lumen of the femoropopliteal artery CTO, in the absence of device-related major adverse events (MAE) through discharge or 24 hours post-procedure, whichever is sooner.

AngioSafe delivers compelling
results where it matters most.

~ 0 %
overall success
> 0 %
crossing in moderate to severe calcification
0
device-related MAEs
0
embolization
0
major perforation
0
flow-limiting dissections
or bailout stent
0
mean crossing

time (min)
0
median crossing

time (min)
0
mean lesion

length (mm)

Built to perform where patient and
lesion complexity converge

0 %
of successful cases were
crossed antegrade only
> 0 %
of successful case crossing
was completed intraluminal
~ 0 %
single access only
In a subset of RESTOR-1 subjects, post-hoc quantitative secondary analysis of imaging data suggests that Santreva-ATK may form
a 2.8mm channel in a 5mm vessel, representing >55% mean lumen gain in femoropopliteal arteries. Data on file.

In a single pass, Santreva ATK successfully crossed even the most complex lesions, irrespective of level of calcification or lesion length

Angiosafe Calcifications

Traditional CTO procedures rely on multiple devices to cross, then open the vessel. Our technology merges those steps delivering a more efficient, streamlined experience with the potential to reduce complications, reduce procedure times, and improve outcomes.

Significant Improvement in Rutherford Classification and Pain Scores

Angiosafe Rutherford Scores

From proximal cap to true lumen
Introducing Santreva-ATK

Santreva-ATK is an all-in-one, large-profile, manually controlled, and guidewire-free endovascular CTO crossing solution, with full force range and control to tackle the wide range of plaque morphologies, designed to limit damage to the vessel wall.

Explore Santreva-ATK

1 RESTOR-1 Study, data on file (ClinicalTrials.gov ID: NCT04663867)