IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA) (INPACT SFA II)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01566461
First received: March 27, 2012
Last updated: July 17, 2015
Last verified: July 2015

March 27, 2012
July 17, 2015
March 2012
February 2014   (final data collection date for primary outcome measure)
  • Primary Patency [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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.
  • Primary Safety Composite [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    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.
Not Provided
Complete list of historical versions of study NCT01566461 on ClinicalTrials.gov Archive Site
  • Major Adverse Event (MAE) Composite [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    Major Adverse Event (MAE) composite is defined as all cause death, clinically-driven target vessel revascularization, major target limb amputation, thrombosis at the target lesion site.
  • All-cause Death [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization (TVR) [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Target Lesion Revascularization (TLR) [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Time to First Clinically Driven Target Lesion Revascularization (CD-TLR) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post procedure baseline.
  • Major Target Limb Amputation [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Thrombosis at the Target Lesion [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Primary Sustained Clinical Improvement [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class.
  • Secondary Sustained Clinical Improvement [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Freedom from target amputation and increase in Rutherford class.
  • Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Quality of Life Assessment by EuroQol Group 5-Dimension Self-Report Questionnaire (EQ5D) [ Time Frame: 12 month ] [ Designated as safety issue: No ]

    Quality of life assessment by EQ5D at 1 year compared to baseline. EQ5D is a standardised measure of health status and economic appraisal. The EQ5D consists of the EQ5D descriptive system which comprises the following variables for the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. A complex algorithm that took individual dimensions and generated an overall score was used.

    EQ5D health state is used in the algorithm to calculate an overall score where - 0.109 = 'worst possible outcome' and 1.000 = 'best possible outcome'.

  • Change in Walking Distance as Assessed by Six Minute Walk Test (6MWT) [ Time Frame: From baseline to 12 month ] [ Designated as safety issue: No ]
    Change from baseline in walking distance by Six Minute Walk Test (6MWT) at 12 month.
  • Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ) [ Time Frame: 12 month ] [ Designated as safety issue: No ]

    Walking capacity assessment by WIQ at 1 year compared to baseline. WIQ is a quality of life questionnaire that was specifically designed to assess the degree of impairment experienced by patients with claudication.

    Clinical outcomes were assessed by patients responses to question 1A. Question 1A is specific for calf or buttocks claudication and is used to create a summary score for analysis. Question 1A is expressed on a scale of 0% (unable to perform because of severe claudication) to 100% (no impairment).

  • Device Success [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below rated burst pressure (RBP).
  • Procedural Success [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Procedural success is defined as residual stenosis of ≤50% (non-stented subjects) or ≤30% (stented subjects) by core lab assessment.
  • Clinical Success [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Clinical success is defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or Target vessel revascularization (TVR)) prior to discharge.
  • Days of Hospitalization Due to the Index Lesion [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Days of hospitalization from procedure through 12 month.
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Not Provided
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IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
Randomized Trial of IN.PACT (Paclitaxel) Admiral Drug-Coated Balloon (DCB) vs. Standard Percutaneous Transluminal Angioplasty (PTA) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)

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.

The IN.PACT SFA Trial enrolled in 2 phases: IN.PACT SFA I and IN.PACT SFA II. The 150-patient IN.PACT SFA I phase is intended to support the second phase IN.PACT SFA II IDE trial with congruent design and protocol. Aggregate data from the two phases is intended to provide statistical power for the 12-month primary safety and effectiveness endpoints.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Femoral Artery Stenosis
  • Popliteal Artery Stenosis
  • Femoral Artery Occlusion
  • Popliteal Artery Occlusion
  • Device: Drug-Coated Balloon (DCB)
    Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
  • Device: PTA Balloon: Balloon Angioplasty
    Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
  • Experimental: Drug-Coated Balloon (DCB)
    IN.PACT Admiral: Balloon Angioplasty
    Intervention: Device: Drug-Coated Balloon (DCB)
  • Active Comparator: Standard PTA
    Standard Percutaneous Balloon Angioplasty (PTA) Balloon: Balloon Angioplasty
    Intervention: Device: PTA Balloon: Balloon Angioplasty
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
331
June 2018
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

    1. 70 - 99% occlusion by visual estimate with lesion length > or equal to 4 cm and < or equal to 18 cm
    2. 100% occlusion by visual estimate with lesion length < or equal to 10 cm
    3. 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

Exclusion Criteria:

  • 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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01566461
10031540DOC
Yes
Medtronic Endovascular
Medtronic Endovascular
Not Provided
Not Provided
Medtronic Endovascular
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP