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Clinical outcomes IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter

Alert Indications, Safety, and Warnings

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
  • Independent and blinded duplex ultrasound core lab, angiographic core lab, and clinical events committee
  • Independent data safety monitoring board
  • External monitoring with 100% source data verification

Patients

331 patients

Sites

57 sites

(U.S., EU)

Key eligibility criteria
  • SFA + proximal popliteal
  • Lesions ≥ 4 cm and ≤ 18 cm
  • RCC 2-4
  • No ISR, severe Ca++

Links to publications

CD-TLR and safety outcomes through five years1

 

IN.PACT SFA
(N = 220 subjects)

PTA
(N = 111 subjects)

P-value‡

Clinically driven TLR§

25.5% 
(47/184)

35.6% 
(37/104)

0.080

Primary safety compositell

70.7% 
(130/184)

59.6% 
(62/104)

0.068

Major adverse events

42.9% 
(79/184)

48.1% 
(50/104)

0.459

All-cause death

15.8% 
(29/184)

9.6% 
(10/104)

0.156

Device- or procedure-related death through five years#

0.0% 
(0/184)

0.0% 
(0/104)

N/A

CD-TVR

29.3% 
(54/184)

40.4% 
(42/104)

0.068

Major target limb amputation

0.5% 
(1/184)

0.0% 
(0/104)

1.000

Thrombosis

2.2% 
(4/184)

4.8% 
(5/104)

0.292 

Primary patency through three years4

Chart showing the IN.PACT SFA Trial results for primary patency through three years for DCB versus PTA

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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™ Paclitaxel-coated PTA Balloon Catheter 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
  • Independent and blinded duplex ultrasound core lab, angiographic core lab, and clinical events committee
  • Independent data safety monitoring board
  • External monitoring with 100% source data verification

Patients

1,535 patients

Sites

64 sites

(EU, Middle East, Latin America, Asia)

Key eligibility criteria
  • SFA and full popliteal
  • Lesions ≥ 2 cm
  • RCC 2-4
  • ISR, severe Ca++

Links to publications

Safety and effectiveness in complex real-world patients through 12 months5-9

 

Lesion length  
(mean + SD, cm)

Primary patency 
(KM @ 360 days)

CD-TLR

Thrombosis

Major target limb amputation

IN.PACT Global (DCB ARM)

(N = 1,406)

12.09
± 9.54

N/A

7.5%

2.9%

0.2%

IN.PACT Global long lesion imaging cohort 

(N = 157)

26.40
± 8.61

91.1%

6.0%

3.7%

0.0%

IN.PACT Global ISR imaging cohort 

(N = 131)

17.17
± 10.47

88.7%

7.3%

0.8%

0.0%

IN.PACT Global CTO imaging cohort 

(N = 126)

22.83
± 9.76

85.3%

11.3%

4.3%

0.0%

IN.PACT Global complex lesion sub-cohort

(N = 227)10

28.74
± 7.11

89.1%

7.1%

3.3%

0.0%

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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™ Paclitaxel-coated PTA Balloon Catheter.

Freedom from CD-TLR through five years11

de novo ISR

Chart showing the IN.PACT Global Study de novo ISR cohorts results for freedom from CD-TLR through five years

Long lesion

Chart showing the IN.PACT Global Study long lesions ISR cohorts results for freedom from CD-TLR through five years

CTO

Chart showing the IN.PACT Global Study CTO cohort results for freedom from CD-TLR through five years

IN.PACT global full cohort five-year freedom from CD-TLR rate: 69.4%11

See the study

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IN.PACT SFA Japan Trial

The IN.PACT SFA Japan Trial continues to demonstrate the durability, consistency, and safety of IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter 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
  • Independent and blinded duplex ultrasound core lab, angiographic core lab, and clinical events committee
  • Independent data safety monitoring board
  • External monitoring with 100% source data verification

Patients

100 patients

Sites

11 sites

(Japan)

Key eligibility criteria
  • SFA and proximal popliteal
  • Lesions ≥ 4 cm and ≤ 20 cm
  • RCC 2-4
  • No ISR, severe Ca++

Links to publications and presentation

CD-TLR and safety outcomes through three years10

 

MDT-2113 DCB
(N = 68 subjects)

PTA
(N = 32 subjects)

 P-value

Clinically driven TLR

14.9%
(10/67)

20.7%
(6/29)

0.554

Primary safety composite‡‡

 

83.6%
(56/67)

75.9%
(22/29)

0.402

30-day device- and procedure-related death

0.0%
(0/68)

0.0%
(0/32)

> 0.999

Major adverse event§§

20.9%
(14/67)

31.0%
(9/29)

0.306

Major target limb amputation

0.0%
(0/67)

0.0%
(0/29)

> 0.999

Clinically driven TVR

16.4%
(11/67)

24.1%
(7/29)

0.402

All-cause death

6.0%
(4/67)

6.9%
(2/29)

1.000

Thrombosis

1.5%
(1/67)

0.0%
(0/29)

1.000

Primary patency through three years10

Chart showing the IN.PACT Japan SFA Trial results for primary patency through three years compared to PTA

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Additional resources

Related pages

Related products

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*

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.

14

 S. Steiner, A. Schmidt, T. Zeller, et al. COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions. EurHeart J. 2020 https://pubmed.ncbi.nlm.nih.gov/31989155/

15

S. Elmariah, G. M Ansel, M. Brodmann, et al. Design and rationale of a randomized noninferiority trial to evaluate the SurVeildrug-coated balloon in subjects with stenotic lesions of the femoropopliteal artery – the TRANSCEND study. Am Heart J. 2019 https://pubmed.ncbi.nlm.nih.gov/30685679/

16

K. Deloose, W. Lansink, M. Brodmann, et al. BIOPACT RCT, a Multi-center, Randomized, Non-inferiority Trial Evaluating Safety and Efficacy of Passeo-18 Lux Drug-Coated Balloon (DCB) of Biotronik Compared to the Medtronic IN.PACTAdmiral DCB in the Treatment of Subjects with Lesions of the Femoropopliteal Artery. Cardiovascular Intervention Radiology 2022 https://pubmed.ncbi.nlm.nih.gov/36058996/

***™Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. The approved product name for the drug-coated balloon is IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter.