NCT01566461

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
331

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 14, 2015

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

February 12, 2019

Status Verified

January 1, 2019

Enrollment Period

1.9 years

First QC Date

March 27, 2012

Results QC Date

February 18, 2015

Last Update Submit

January 29, 2019

Conditions

Femoral Artery StenosisPopliteal Artery StenosisFemoral Artery OcclusionPopliteal Artery Occlusion

Keywords

Drug-Coated Angioplasty BalloonDrug Coated Angioplasty BalloonPeripheral Artery DiseaseExperimentalPercutaneous Transluminal Angioplasty (PTA)

Outcome Measures

Primary Outcomes (2)

  • Primary Patency

    Primary patency is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤2.4.

    12 month

  • Primary Safety Composite

    Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.

    12 month

Secondary Outcomes (18)

  • Major Adverse Event (MAE) Composite

    12 month

  • All-cause Death

    12 month

  • Target Vessel Revascularization (TVR)

    12 month

  • Target Lesion Revascularization (TLR)

    12 month

  • Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)

    12 month

  • +13 more secondary outcomes

Study Arms (2)

Drug-Coated Balloon (DCB)

EXPERIMENTAL

IN.PACT Admiral: Balloon Angioplasty

Device: Drug-Coated Balloon (DCB)

Standard PTA

ACTIVE COMPARATOR

Standard Percutaneous Balloon Angioplasty (PTA) Balloon: Balloon Angioplasty

Device: PTA Balloon: Balloon Angioplasty

Interventions

Drug-Coated Balloon (DCB)DEVICE

Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Drug-Coated Balloon (DCB)
PTA Balloon: Balloon AngioplastyDEVICE

Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Standard PTA

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: \> or equal to 18 years and \< or equal to 85 years
  • Documented ischemia with Rutherford classification 2, 3, or 4
  • Target lesion in the SFA and/or PPA
  • Angiographic evidence that target lesion consists of a single de novo or non-stented restenotic lesion or is a combination lesion that meets the following criteria:
  • % occlusion by visual estimate with lesion length \> or equal to 4 cm and \< or equal to 18 cm
  • % occlusion by visual estimate with lesion length \< or equal to 10 cm
  • Combination lesions must have a total lesion length of \> or equal to 4 cm and \< or equal to 18 cm with an occluded segment that is \< or equal to 10 cm (by visual estimate)
  • Target vessel diameter \> 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Washington Hospital

Fremont, California, 94538, United States

Location

Kaiser Permanente Hawaii

Honolulu, Hawaii, 96819, United States

Location

Related Publications (7)

  • Krishnan P, Farhan S, Schneider P, Kamran H, Iida O, Brodmann M, Micari A, Sachar R, Urasawa K, Scheinert D, Ando K, Tarricone A, Doros G, Tepe G, Yokoi H, Laird J, Zeller T. Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. J Am Coll Cardiol. 2022 Sep 27;80(13):1241-1250. doi: 10.1016/j.jacc.2022.06.043.

    PMID: 36137674DERIVED

  • Shishehbor MH, Schneider PA, Zeller T, Razavi MK, Laird JR, Wang H, Tieche C, Parikh SA, Iida O, Jaff MR. Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts. J Vasc Surg. 2019 Oct;70(4):1177-1191.e9. doi: 10.1016/j.jvs.2019.02.030.

    PMID: 31543165DERIVED

  • Laird JA, Schneider PA, Jaff MR, Brodmann M, Zeller T, Metzger DC, Krishnan P, Scheinert D, Micari A, Wang H, Masters M, Tepe G. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. Circ Cardiovasc Interv. 2019 Jun;12(6):e007702. doi: 10.1161/CIRCINTERVENTIONS.118.007702. Epub 2019 Jun 14.

    PMID: 31195825DERIVED

  • Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. 2019 May 28;73(20):2550-2563. doi: 10.1016/j.jacc.2019.01.013. Epub 2019 Jan 25.

    PMID: 30690141DERIVED

  • Schneider PA, Laird JR, Tepe G, Brodmann M, Zeller T, Scheinert D, Metzger C, Micari A, Sachar R, Jaff MR, Wang H, Hasenbank MS, Krishnan P; IN.PACT SFA Trial Investigators. 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. 2018 Jan;11(1):e005891. doi: 10.1161/CIRCINTERVENTIONS.117.005891.

    PMID: 29326153DERIVED

  • Laird JR, Schneider PA, Tepe G, Brodmann M, Zeller T, Metzger C, Krishnan P, Scheinert D, Micari A, Cohen DJ, Wang H, Hasenbank MS, Jaff MR; IN.PACT SFA Trial Investigators. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol. 2015 Dec 1;66(21):2329-2338. doi: 10.1016/j.jacc.2015.09.063. Epub 2015 Oct 14.

    PMID: 26476467DERIVED

  • Tepe G, Laird J, Schneider P, Brodmann M, Krishnan P, Micari A, Metzger C, Scheinert D, Zeller T, Cohen DJ, Snead DB, Alexander B, Landini M, Jaff MR; IN.PACT SFA Trial Investigators. 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. 2015 Feb 3;131(5):495-502. doi: 10.1161/CIRCULATIONAHA.114.011004. Epub 2014 Dec 3.

    PMID: 25472980DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Results Point of Contact

Title
Arslan Malik, Sr. Clinical Research Manager
Organization
Medtronic Endovascular Therapies
arslan.malik@medtronic.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2012

First Posted

March 29, 2012

Study Start

March 1, 2012

Primary Completion

February 1, 2014

Study Completion

May 1, 2018

Last Updated

February 12, 2019

Results First Posted

July 14, 2015

Record last verified: 2019-01

Locations

US(2)