IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter clinical program
The IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter clinical program covers multiple trials and patient populations with varying disease states. The data collected is robust and demonstrates the durability, consistency, and safety of the IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter as a proven therapy for patients with peripheral artery disease.
IN.PACT SFA Trial
The outcomes from the IN.PACT SFA Trial demonstrate long-term safety and effectiveness, with 75% of patients reintervention-free through five years.1
Clinical trial design
| Study type |
Prospective, multicenter, randomized, controlled pivotal trial |
|---|---|
| Primary endpoints |
Effectiveness: primary patency* Safety: safety composite† |
| Rigor and quality |
|
| Patients |
331 patients |
| Sites |
57 sites (U.S., EU) |
| Key eligibility criteria |
|
Links to publications
- IN.PACT SFA 1-year2
- Tepe G, et al. Circulation. 2015;131:495-502.
- IN.PACT SFA 2-year3
- Laird J, et al. J Am Coll Cardiol. 2015;66:2329-2338.
- IN.PACT SFA 3-year4
- Schneider PA, et al. Circ Cardiovasc Interv. 2018;11:e005891.
- IN.PACT SFA 5-year1
- Laird J, et al. Circ Cardiovasc Interv. 2019;12:e007702.
CD-TLR and safety outcomes through five years1
|
|
IN.PACT SFA |
PTA |
P-value‡ |
|---|---|---|---|
| Clinically driven TLR§ |
25.5% |
35.6% |
0.080 |
| Primary safety compositell |
70.7% |
59.6% |
0.068 |
| Major adverse events¶ |
42.9% |
48.1% |
0.459 |
| All-cause death |
15.8% |
9.6% |
0.156 |
| Device- or procedure-related death through five years# |
0.0% |
0.0% |
N/A |
| CD-TVR |
29.3% |
40.4% |
0.068 |
| Major target limb amputation |
0.5% |
0.0% |
1.000 |
| Thrombosis |
2.2% |
4.8% |
0.292 |
Primary patency through three years4
IN.PACT Global Study
The IN.PACT Global Study was a real-world registry of 1,535 patients from 64 sites across the globe. This study proved the durability, consistency, and safety of the IN.PACT Admiral DCB in complex patients and lesion types.
Clinical trial design
| Study type |
Prospective, multicenter, single-arm study |
|---|---|
| Primary endpoints |
Effectiveness: freedom from CD-TLR (all subjects)†† Effectiveness: primary patency (imaging cohort) Safety: safety composite† |
| Rigor and quality |
|
| Patients |
1,535 patients |
| Sites |
64 sites (EU, Middle East, Latin America, Asia) |
| Key eligibility criteria |
|
Links to publications
- IN.PACT Global 1-year5
- Zeller T, et al. Circ Cardiovasc Interv. 2019; 118.007730.
- IN.PACT Global — Long Lesion6
- Scheinert D, et al. Circ Cardiovasc Interv. 2018;11:e005654.
- IN.PACT Global — ISR7
- Brodmann M, et al. JACC Cardiovasc Interv. 2017;10:2113-2123.
- IN.PACT Global — CTO8
- Tepe G, et al. JACC Cardiovasc Interv. 2019;12:484-493.
- IN.PACT Global — CLI9
- Reijnen MMPJ, et al. J Endovasc Ther. 2019;26:305-315.
Safety and effectiveness in complex real-world patients through 12 months5-9
|
|
Lesion length |
Primary patency |
CD-TLR |
Thrombosis |
Major target limb amputation |
|---|---|---|---|---|---|
| IN.PACT Global (DCB ARM) (N = 1,406) |
12.09 |
N/A |
7.5% |
2.9% |
0.2% |
| IN.PACT Global long lesion imaging cohort (N = 157) |
26.40 |
91.1% |
6.0% |
3.7% |
0.0% |
| IN.PACT Global ISR imaging cohort (N = 131) |
17.17 |
88.7% |
7.3% |
0.8% |
0.0% |
| IN.PACT Global CTO imaging cohort (N = 126) |
22.83 |
85.3% |
11.3% |
4.3% |
0.0% |
| IN.PACT Global complex lesion sub-cohort (N = 227)10 |
28.74 |
89.1% |
7.1% |
3.3% |
0.0% |
IN.PACT Global Study: Pre-specified Cohorts
Real-world data from the IN.PACT Global Study confirms long-term clinical safety and effectiveness of IN.PACT Admiral DCB.
Freedom from CD-TLR through five years11
de novo ISR
Long lesion
CTO
IN.PACT global full cohort five-year freedom from CD-TLR rate: 69.4%11
IN.PACT SFA Japan Trial
The IN.PACT SFA Japan Trial continues to demonstrate the durability, consistency, and safety of IN.PACT Admiral DCB compared to PTA.
Clinical trial design
| Study type |
Prospective, multicenter, randomized, controlled pivotal trial |
|---|---|
| Primary endpoints |
Effectiveness: primary patency† Safety: safety composite† |
| Rigor and quality |
|
| Patients |
100 patients |
| Sites |
11 sites (Japan) |
| Key eligibility criteria |
|
Links to publications and presentation
- IN.PACT Japan 1-year12
- Iida O, et al. J Endovasc Ther. 2018;25:109-117.
- IN.PACT Japan 2-year13
- Iida O, et al. Catheter Cardiovasc Interv. 2019;93:664-672.
- IN.PACT Japan 3-year10
- Iida O. Presented at LINC 2019; Leipzig, Germany.
CD-TLR and safety outcomes through three years10
|
|
MDT-2113 DCB |
PTA |
P-value |
|---|---|---|---|
| Clinically driven TLR |
14.9% |
20.7% |
0.554 |
| Primary safety composite‡‡
|
83.6% |
75.9% |
0.402 |
| 30-day device- and procedure-related death |
0.0% |
0.0% |
> 0.999 |
| Major adverse event§§ |
20.9% |
31.0% |
0.306 |
| Major target limb amputation |
0.0% |
0.0% |
> 0.999 |
| Clinically driven TVR |
16.4% |
24.1% |
0.402 |
| All-cause death |
6.0% |
6.9% |
1.000 |
| Thrombosis |
1.5% |
0.0% |
1.000 |
Primary patency through three years10
Additional resources
Related pages
Related products
Connect with us
*
Freedom from CD-TLR and DUS-derived restenosis (PSVR ≤ 2.4) at 12 months.
†
Composite 30-day freedom for device- and procedure-related mortality and 12-month freedom from major target limb amputation and CD-TVR.
‡
Unless otherwise indicated, all tests were for superiority using the Fisher’s exact test for binary variables and t-test for continuous variables.
§
Clinically driven TLR adjudicated by an independent Clinical Event Committee, blinded to the assigned treatment based on any reintervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-procedure baseline ABI.
||
Safety Composite Endpoint consists of: Freedom from device- and procedure-related death through 30 days post-index procedure and freedom from target limb major amputation and clinically driven target vessel revascularization (TVR) within 12 months post-index procedure.
¶
Composite of death, clinically driven TVR, target limb major amputation, and thrombosis.
#
All deaths adjudicated by the CEC.
**
Number at risk represents the number of evaluable subjects at the beginning of each 30-day window.
††
Defined as TLR due to symptoms or drop of ABI/TBI of > 20% or > 0.15 when compared to post-procedure baseline ABI/TBI.
‡‡
Primary safety composite is defined as freedom from device- and procedure-related 30-day death and freedom from target limb major amputation and clinically driven TVR through 36 months.
§§
MAE is defined as composite of death, clinically driven TVR, target limb major amputation, and thrombosis within 36 months.
References
1
Laird JA, Schneider PA, Jaff MR, et al. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. 5-year results from the IN.PACT SFA Trial. Circ Cardiovasc Interv. June 2019;12(6):e007702.
2
Tepe G, Laird J, Schneider P, et al. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation. February 3, 2015;131(5):495-502.
3
Laird J, Schneider PA, Tepe G, et al. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol. December 1, 2015;66(21):2329-2338.
4
Schneider PA, Laird J, Tepe G, et al. Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial. Circ Cardiovasc Interv. January 2018;11(1):e005891.
5
Zeller T, Ansel GM, Brodmann M, Keirse K, et al. Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study. J Endovasc Ther. December 2018;25(6):673-682.
6
Scheinert D, Micari A, Brodmann M, et al. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease. Circ Cardiovasc Interv. October 2018;11(10):e005654.
7
Brodmann M, Keirse K, Scheinert D, et al. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The IN.PACT Global Study De Novo In-Stent Restenosis Imaging Cohort. JACC Cardiovasc Interv. October 23, 2017;10(20):2113-2123.
8
Tepe G, Micari A, Keirse K, et al. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study. JACC Cardiovasc Interv. March 11, 2019;12(5):484-493.
9
Reijnen MMPJ, van Wijck I, Zeller T, et al. Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study. J Endovasc Ther. June 2019;26(3):305-315.
10
Iida O. 3-Year Results from the MDT-2113 SFA Japan Trial. DCB vs. standard PTA for the treatment of atherosclerotic lesions in the SFA/PPA. Presented at LINC 2019; Leipzig, Germany.
11
Tepe G. 5-year results from the IN.PACT Global Study Prespecified Cohorts: ISR, CTO and Long Lesions. Presented at VIVA, 2021.
12
Iida O, Soga Y, Urasawa K, et al. Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial. J Endovasc Ther. February 2018;25(1):109-117.
13
Iida O, Soga Y, Urasawa K et al. Drug-coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2-year results of the MDT-2113 SFA Japan randomized trial. Catheter Cardiovasc Interv. March 1, 2019;93(4):664-672.