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IN.PACT Global Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01609296
Recruitment Status : Active, not recruiting
First Posted : May 31, 2012
Results First Posted : January 28, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Brief Summary:
The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: IN.PACT Admiral™ Drug Eluting Balloon Not Applicable

Detailed Description:

Peripheral artery disease (PAD) commonly results from progressive narrowing of the arteries in the lower extremities, usually due to atherosclerosis. Progression of PAD can result in critical limb ischemia (CLI), manifested by ischemic pain at rest or in the breakdown of the skin, resulting in ulcers or gangrene which ultimately may lead to amputation and death.

The IN.PACT Global Clinical Study aims to expand and understand the safety and efficacy data on the IN.PACT Admiral™ DEB in a real world population of subjects with intermittent claudication and/or rest pain (Rutherford class 2-3-4) due to obstructive disease of the superficial femoral and/or popliteal arteries.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1535 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon.
Study Start Date : May 2012
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Experimental: IN.PACT Admiral DEB
The subjects in this trial will be treated with the IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon (hereinafter referred as "IN.PACT Admiral™ DEB")manufactured by Medtronic. The IN.PACT Admiral™ is a CE (Conformité Europeénne, European Confirmity) marked medical device utilized within its intended use in the IN.PACT Global trial.
Device: IN.PACT Admiral™ Drug Eluting Balloon
IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.




Primary Outcome Measures :
  1. Primary Endpoint Clinical Cohort [ Time Frame: 12 months ]
    Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  2. Primary Safety Endpoint [ Time Frame: 12 months ]
    A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.


Secondary Outcome Measures :
  1. MAEs [ Time Frame: 12 months ]
    MAE (Major Adverse Events)is defined as all-cause mortality, clinically-driven TVR (Target Vessel Revascularization), major target limb amputation, thrombosis at the target lesion site.

  2. TLR [ Time Frame: 12 months ]
    Any Target lesion revascularisation

  3. TVR [ Time Frame: 12 months. ]
    Any Target vessel revascularisation

  4. Primary Sustained Clinical Improvement [ Time Frame: 12 months. ]
    Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  5. Device Success [ Time Frame: Index-procedure ]
    Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)

  6. Clinical Success [ Time Frame: prior to discharge ]
    Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General inclusion Criteria:

  • Age ≥ 18 years or minimum age as required by local regulations.
  • Subject with documented diagnosis of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and/or popliteal artery (PA) (including P1, P2, P3) classified as Rutherford class 2-3-4.
  • Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis) within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days.

General exclusion Criteria:

  • High probability of non-adherence to Clinical Investigation Protocol follow-up requirements.
  • Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
  • Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609296


  Show 68 Study Locations
Sponsors and Collaborators
Medtronic Endovascular
Investigators
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Principal Investigator: Gunnar Tepe, MD Klinikum Rosenheim
Principal Investigator: Gary Ansel, MD MidOhio Cardiology and Vascular Consultants
Principal Investigator: Marc Bosiers, MD AZ Sint Blasius
Principal Investigator: Do-Dai Do, MD Swiss Cardiovascular Center, Inselspital
Principal Investigator: Peter Gaines, MD Sheffield Vascular Institute
Principal Investigator: Alvaro Razuk, MD Faculdade de Ciências Médicas da Santa Casa de Sao Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01609296     History of Changes
Other Study ID Numbers: 10048613
First Posted: May 31, 2012    Key Record Dates
Results First Posted: January 28, 2019
Last Update Posted: February 15, 2019
Last Verified: February 2019
Keywords provided by Medtronic Endovascular:
Peripheral Arterial Disease
Drug coated balloon
Superficial Femoral Artery
Popliteal Femoral Artery
Atherosclerosis
Drug eluting balloon
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases