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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Medtronic Endovascular

ClinicalTrials.gov Identifier:

NCT01566461

First received: March 27, 2012

Last updated: January 30, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	March 27, 2012
Last Updated Date	January 30, 2013
Start Date ^ICMJE	March 2012
Estimated Primary Completion Date	March 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 10, 2012)	Efficacy: Primary patency [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] Primary patency is defined as freedom from clinically driven target lesion revascularization (TLR) and freedom from restenosis as determined by duplex ultrasound (DUS) Safety: Composite of freedom from device and procedure-related death through 30 days post procedure, and freedom from both target limb major amputation and clinically-driven target vessel revascularization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01566461 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 10, 2012)	Target Lesion Revascularization (TLR) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] Rate of target lesion revascularizations Rutherford Classification [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] An improvment shift in the Rutherford classification of at least on class in amputation and TVR-free surviving subjects Walking Distance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] Change in walking distance from baseline as assessed by 6 Minute Walk Test Binary Restenosis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ] Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion at 24 months or at the time of reintervention
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	IN.PACT Admiral Drug-Eluting Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
Official Title ^ICMJE	Randomized Trial of IN.PACT (Paclitaxel) Admiral Drug-Eluting Balloon (DEB) vs. Standard Percutaneous Transluminal Angioplasty (PTA) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)
Brief Summary	The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-eluting balloon in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial femoral artery and proximal popliteal artery.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Femoral Artery Stenosis Popliteal Artery Stenosis Femoral Artery Occlusion Popliteal Artery Occlusion
Intervention ^ICMJE	Device: IN.PACT Admiral Drug-Eluting Balloon Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Eluting Balloon Arm or to the standard angioplasty balloon Arm Device: Standard angioplasty balloon Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Eluting Balloon Arm or to the standard angioplasty balloon Arm
Study Arm (s)	Experimental: IN.PACT Admiral Drug-Eluting Balloon Paclitaxel drug-eluting angioplasty balloon Intervention: Device: IN.PACT Admiral Drug-Eluting Balloon Active Comparator: Standard angioplasty balloon Standard angioplasty balloon without Paclitaxel drug-elution Intervention: Device: Standard angioplasty balloon
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	450
Estimated Completion Date	March 2018
Estimated Primary Completion Date	March 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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: 70 - 99% occlusion by visual estimate with lesion length > or equal to 4 cm and < or equal to 18 cm 100% 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 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
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01566461
Other Study ID Numbers ^ICMJE	10031540DOC
Has Data Monitoring Committee	Yes
Responsible Party	Medtronic Endovascular
Study Sponsor ^ICMJE	Medtronic Endovascular
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Medtronic Endovascular
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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