CLINICAL PROGRAM DESIGN 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 Patency*
Safety: Safety Composite† 

Efficacy: Freedom from CD-TLR‡ (All Subjects);
Primary Patency (Imaging Cohort)
Safety: Safety Composite† 

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

1535
131 de novo In-Stent Restenosis (ISR) Subset
157 Long Lesion Subset
126 Chronic Total Occlusion (CTO) Subset

# Sites + Location

57
US + EU

67
Global

Key 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

* Freedom from CD-TLR‡ and DUS-derived restenosis (PSVR ≤ 2.4) at 12 months

 Composite 30-day freedom from device- and procedure-related mortality and 12-month freedom from major target limb amputation and CD-TVR

 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/TB


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

Patient Population Comparison