NCT01175850

Brief Summary

The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral® drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery, as compared to other standard (non drug coated) PTA balloons. The IN.PACT Admiral, besides the mechanical dilatation effect typical of all PTA balloons, releases a drug (paclitaxel) from the balloon surface into the vessel walls. This drug absorption is intended to limit the chances and the entity of artery re-narrowing over time.

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 Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2010

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

October 6, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 16, 2017

Status Verified

April 1, 2017

Enrollment Period

3.4 years

First QC Date

August 3, 2010

Results QC Date

February 24, 2015

Last Update Submit

April 12, 2017

Conditions

Peripheral Arterial Disease (PAD)

Outcome Measures

Primary Outcomes (2)

  • Primary Patency

    Primary patency is defined as freedom from clinically-driven target lesion revascularization (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 (17)

  • Major Adverse Events (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

  • +12 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 Transluminal Angioplasty (PTA) Balloon: Balloon Angioplasty

Device: PTA Balloon: Balloon Angioplasty

Interventions

Drug-Coated Balloon (DCB)DEVICE

balloon dilatation and provisional stenting with IN.PACT DCB

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

balloon dilatation and provisional stenting with standard non-coated PTA balloon

Standard PTA

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years and ≤85 years
  • Patient or patient's legal representative is informed of the nature of the study, agrees to participate and has signed an EC approved consent form
  • \- Target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee)

You may not qualify if:

  • Patient unwilling or unlikely to comply with follow-up schedule
  • Stroke or STEMI within 3 months prior enrolment
  • \- Acute or sub-acute thrombus in the target vessel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Rosenheim Institut für Diagnostische und Interventionelle Radiologie

Rosenheim, Pettenkoferstr, 83022, Germany

Location

Related Publications (6)

  • 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

  • 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
Clinical Research Director
Organization
Medtronic - CardioVascular
kristel.wittebols@medtronic.com
+31433566580

Study Officials

  • Gunnar Tepe, Prof Dr. Med

    Klinikum Rosenheim

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2010

First Posted

August 5, 2010

Study Start

September 1, 2010

Primary Completion

February 1, 2014

Study Completion

April 1, 2017

Last Updated

May 16, 2017

Results First Posted

October 6, 2015

Record last verified: 2017-04

Locations

DE(1)