Banner US IN.PACT Admiral Drug Coated Balloon

IN.PACT SFA and IN.PACT Global
Translating Evidence to Practice.

IN.PACT SFA and IN.PACT Global are rigorous, independently-adjudicated clinical evidence studies supporting IN.PACT Admiral DCB therapy in femoropopliteal lesions.

  • IN.PACT SFA is a Level 1 clinical evidence trial evaluating the safety and effectiveness of IN.PACT Admiral vs. standard PTA
  • IN.PACT Global sets a new standard in the real-world assessment of femoropopliteal revascularization

Complementary Study Designs
 

  IN.PACT SFA IN.PACT Global
Study Type Randomized, Controlled Pivotal Trial Single-Arm Study
Primary Endpoints Efficacy: Primary Patency1
Safety: Safety Composite2
Efficacy: Freedom from CD-TLR3 (All Subjects);
Primary Patency (Imaging Cohort)
Safety: Safety Composite2
Rigor + Quality Prospective, Multi-Center Independent Clinical Events Committee (Blinded IN.PACT SFA)
Independent Core Lab Adjudication (Blinded IN.PACT SFA)
External Monitoring
# Patients 331
220 DCB Arm
1500+
150+ In-Stent Restenosis Subset
150+ Long Lesion Subset
150+ Chronic Total Occlusion (CTO) Subset
# Sites + Location 57
US + EU
67
Global
Key Eligiblity Criteria Single lesions ≤ 18cm, CTO ≤ 10cm
TASC A-C
SFA + Proximal Popliteal
No ISR, Ca++
Single or multiple lesions ≥ 2cm
All TASC
SFA + Full Popliteal
ISR, Ca++, CTO
1. Freedom from CD-TLR3 and DUS-derived restenosis (PSVR ≤ 2.4) at 12 months
2. Composite 30-day freedom from device- and procedure-related mortality and 12-month freedom from major target limb amputation and CD-TVR
3. Defined as re-intervention at target lesion due to symptoms or drop of ABI/TBI of ≥20% or >0.15 when compared to post-procedure baseline ABI/TBI

IN.PACT SFA and IN.PACT Global Patient Population Comparison


Patient Population Comparison


 

UC201301645f EN