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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

Tracking Information
First Submitted Date  ICMJE May 24, 2012
First Posted Date  ICMJE May 31, 2012
Results First Submitted Date  ICMJE May 4, 2017
Results First Posted Date  ICMJE January 28, 2019
Last Update Posted Date February 15, 2019
Study Start Date  ICMJE May 2012
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2012)
  • Primary Endpoint Clinical Cohort [ Time Frame: 12 months ]
    Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure.
  • Primary Endpoint Imaging Cohort [ Time Frame: 12 months ]
    Primary Patency within 12 months post-index procedure.
  • 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.
Change History Complete list of historical versions of study NCT01609296 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
  • 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.
  • TLR [ Time Frame: 12 months ]
    Any Target lesion revascularisation
  • TVR [ Time Frame: 12 months. ]
    Any Target vessel revascularisation
  • 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.
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2012)
  • Major Adverse events [ Time Frame: 30 days, 6, 12, 24, 36, 48 and 60 months ]
    - MAE (Major Adverse Events)is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
  • Target lesion restenosis [ Time Frame: 30 days. 6, 12, 24, 36 months ]
    Imaging Cohort: -Duplex-defined binary restenosis of the target lesion at 12 months, or at the time of re-intervention.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IN.PACT Global Clinical Study
Official Title  ICMJE 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.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE Device: IN.PACT Admiral™ Drug Eluting Balloon
IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.
Study Arms  ICMJE 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.
Intervention: Device: IN.PACT Admiral™ Drug Eluting Balloon
Publications *

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 20, 2017)
1535
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2012)
1500
Estimated Study Completion Date  ICMJE August 2021
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Canada,   Colombia,   Czechia,   Egypt,   Finland,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Korea, Republic of,   Lithuania,   Netherlands,   Poland,   Portugal,   Russian Federation,   Singapore,   Slovakia,   Slovenia,   Sweden,   Switzerland,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01609296
Other Study ID Numbers  ICMJE 10048613
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Endovascular
Study Sponsor  ICMJE Medtronic Endovascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Medtronic Endovascular
Verification Date February 2019

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