Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Randomized Trial of IN.PACT Admiral(TM) Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease (INPACT SFA I)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medtronic Endovascular Identifier:
First received: August 3, 2010
Last updated: January 15, 2015
Last verified: January 2015

The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral(TM) drug eluting PTA balloon, utilized for the dilatation of the narrowed sections of the artery, as compared to other standard (non drug eluting) PTA balloons. The IN.PACT Admiral(TM), 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.

Condition Intervention
Peripheral Arterial Disease (PAD)
Device: drug eluting balloon
Device: standard percutaneous transluminal angioplasty (PTA) balloon

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of IN.PACT Admiral(TM) Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Primary Efficacy [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Primary patency is defined as freedom from clinically-driven target lesion revascularisation (TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤ 2.43

  • Primary Safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Freedom from death

Secondary Outcome Measures:
  • Secondary Safety Endpoint [ Time Frame: 60 Months ] [ Designated as safety issue: Yes ]
    MAE (Major Adverse Events)defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site

Estimated Enrollment: 150
Study Start Date: September 2010
Estimated Study Completion Date: June 2016
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IN.PACT Admiral Balloon Device: drug eluting balloon
balloon dilatation and provisional stenting with IN.PACT DEB
Active Comparator: Standard non-coated PTA balloons Device: standard percutaneous transluminal angioplasty (PTA) balloon
balloon dilatation and provisional stenting with standard non-coated PTA balloon

Detailed Description:

The efficacy of the IN.PACT Admiral(TM) balloon will be evaluated by assessing the primary patency rate of the treated arteries in the thighs of all patients included in the Study. Primary patency is a measure of the durability up to 1 year of the free lumen in the artery as restored during the procedure and is based on:

  • the need for re-dilatation of the previously treated vessel segment
  • an ultrasound examination The safety of the IN.PACT Admiral(TM) will be assessed by evaluating the incidence of deaths, amputations and re-dilatation of the pre-treated arteries in all patients included in the Study.

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

General Inclusion Criteria:

  • 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

Angiographic Inclusion Criteria:

- Target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee)

General Exclusion Criteria:

  • Patient unwilling or unlikely to comply with follow-up schedule
  • Stroke or STEMI within 3 months prior enrolment

Angiographic Exclusion Criteria:

- Acute or sub-acute thrombus in the target vessel

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01175850

Klinikum Rosenheim Institut für Diagnostische und Interventionelle Radiologie
Rosenheim, Pettenkoferstr, Germany, 83022
Sponsors and Collaborators
Medtronic Endovascular
Principal Investigator: Gunnar Tepe, Prof Dr. Med Klinikum Rosenheim
  More Information

No publications provided

Responsible Party: Medtronic Endovascular Identifier: NCT01175850     History of Changes
Other Study ID Numbers: P990
Study First Received: August 3, 2010
Last Updated: January 15, 2015
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on February 27, 2015