N/A
N=150
IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
Femoral Artery Stenosis · Popliteal Artery Stenosis · Femoral Artery Occlusion · Popliteal Artery Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT01566461 ↗Enrolled (actual)
150
Serious AEs
49.6%
Results posted
Jul 2015
Primary outcome: Primary: Primary Patency — 82.2; 52.4 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Drug-Coated Balloon (DCB) (Device); PTA Balloon: Balloon Angioplasty (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Endovascular
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Patency |
82.2; 52.4 | <0.001 sig |
| PRIMARY Primary Safety Composite |
95.7; 76.6 | <0.001 sig |
| SECONDARY Major Adverse Event (MAE) Composite |
6.3; 24.3 | <0.001 sig |
| SECONDARY All-cause Death |
1.9; 0 | 0.926 |
| SECONDARY Target Vessel Revascularization (TVR) |
4.8; 23.4 | <0.001 sig |
| SECONDARY Target Lesion Revascularization (TLR) |
2.9; 20.6 | <0.001 sig |
| SECONDARY Time to First Clinically Driven Target Lesion Revascularization (CD-TLR) |
144.6; 201.9 | 0.859 |
| SECONDARY Major Target Limb Amputation |
0; 0 | >0.999 |
| SECONDARY Thrombosis at the Target Lesion |
1.4; 3.7 | 0.096 |
| SECONDARY Primary Sustained Clinical Improvement |
85.2; 68.9 | <0.001 sig |
| SECONDARY Secondary Sustained Clinical Improvement |
89.3; 84.6 | 0.121 |
| SECONDARY Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4) |
16.5; 33.7 | 0.001 sig |
| SECONDARY Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4) |
7.3; 21.4 | <0.001 sig |
| SECONDARY Quality of Life Assessment by EuroQol Group 5-Dimension Self-Report Questionnaire (EQ5D) |
0.1059; 0.0730 | 0.095 |
| SECONDARY Change in Walking Distance as Assessed by Six Minute Walk Test (6MWT) |
38.7; 59.1 | 0.878 |
| SECONDARY Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ) |
72.7; 73.6 | 0.590 |
| SECONDARY Device Success |
99.0; 98.5 | 0.302 |
| SECONDARY Procedural Success |
99.5; 98.2 | 0.111 |
| SECONDARY Clinical Success |
99.1; 97.3 | 0.103 |
| SECONDARY Days of Hospitalization Due to the Index Lesion |
1.3; 1.7 | 0.049 sig |
Summary
The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial femoral artery and proximal popliteal artery.
Eligibility Criteria
Inclusion Criteria
- Age: > or equal to 18 years and or equal to 4 cm and or equal to 4 cm and or equal to 4 mm and < or equal to 7 mm
- Angiographic evidence of adequate distal run-off to the ankle
- Able to walk without assistive devices
Exclusion Criteria
- Stroke or heart attack within 3 months prior to enrollment
- Enrolled in another investigational drug, device or biologic study
- Any surgical procedure or intervention performed within 30 days prior to or post index procedure
- SFA or PPA disease in the opposite leg that requires treatment at the index procedure
- Failure to successfully cross the target lesion
- Angiographic evidence of severe calcification
- Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices)
- Known allergies or sensitivity to heparin, aspirin, other anticoagulant/antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
- Chronic kidney disease
Data sourced from ClinicalTrials.gov (NCT01566461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.