IN.PACT Global Clinical Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01609296
First received: May 24, 2012
Last updated: June 17, 2016
Last verified: June 2016

May 24, 2012
June 17, 2016
May 2012
April 2016   (final data collection date for primary outcome measure)
  • Primary Endpoint Clinical Cohort [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 Endpoint Imaging Cohort [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Primary Patency within 12 months post-index procedure, which is defined as: Freedom from clinically-driven TLR and • Freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.4 Restenosis determined by either PSVR >2.4 as assessed by an independent DUS core lab or >50% stenosis as assessed by an independent angiographic core lab
  • Primary Safety Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.
  • Primary Endpoint Clinical Cohort [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure.
  • Primary Endpoint Imaging Cohort [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Primary Patency within 12 months post-index procedure.
  • Primary Safety Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.
Complete list of historical versions of study NCT01609296 on ClinicalTrials.gov Archive Site
  • MAEs [ Time Frame: 30 days, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]
    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.
  • All-cause mortality [ Time Frame: at 30 days, 6, 12, 24, 36, 48 and 60 months. ] [ Designated as safety issue: Yes ]
  • Clinically-driven TLR [ Time Frame: at 30 days, 6, 24, 36, 48 and 60 months. ] [ Designated as safety issue: Yes ]
  • Clinically-driven TVR [ Time Frame: at 30 days, 6, 12, 24, 36, 48 and 60 months. ] [ Designated as safety issue: Yes ]
    Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
  • TLR [ Time Frame: at 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]
  • TVR [ Time Frame: at 6, 12, 24, 36, 48 and 60 months. ] [ Designated as safety issue: Yes ]
  • Major target limb amputation [ Time Frame: at 30 days, 6, 12, 24, 36, 48 and 60 months. ] [ Designated as safety issue: Yes ]
  • Time to first clinically-driven TLR [ Time Frame: through 60 months post-index procedure. ] [ Designated as safety issue: Yes ]
  • Time to all-cause mortality [ Time Frame: through 60 months post-index procedure. ] [ Designated as safety issue: Yes ]
  • Primary sustained clinical improvement [ Time Frame: at 6, 12, 24, 36 months. ] [ Designated as safety issue: Yes ]
    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.
  • Secondary sustained clinical improvement [ Time Frame: at 6, 12, 24, 36 months. ] [ Designated as safety issue: Yes ]
    Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
  • Immediate hemodynamic improvement [ Time Frame: at post-index procedure. ] [ Designated as safety issue: Yes ]
    Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9.
  • Sustained hemodynamic improvement [ Time Frame: at 6, 12, 24, 36 months. ] [ Designated as safety issue: Yes ]
    Sustained hemodynamic improvement is defined as persistent improvement of ABI-values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
  • Walking impairment evaluation by Walking Impairment Questionnaire (WIQ) [ Time Frame: at 6, 12, 24, 36 months. ] [ Designated as safety issue: Yes ]
  • Walking distance as measured by 6 Minute Walk Test [ Time Frame: at 6, 12, 24, 36 months. ] [ Designated as safety issue: Yes ]
  • Health related Quality of life scores (EQ5D) [ Time Frame: at 6, 12, 24, 36 months ] [ Designated as safety issue: Yes ]
  • Device success [ Time Frame: Index-procedure ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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
  • Imaging cohort: Duplex-defined binary restenosis (PSVR > 2.0) of the target lesion [ Time Frame: at 12 months, or at the time of re-intervention. ] [ Designated as safety issue: Yes ]
  • Imaging cohort: 21. Duplex-defined binary restenosis (PSVR > 3.4) of the target lesion [ Time Frame: at 12 months, or at the time of re-intervention. ] [ Designated as safety issue: Yes ]
  • Major Adverse events [ Time Frame: 30 days, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]
    - 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 ] [ Designated as safety issue: Yes ]

    Imaging Cohort:

    -Duplex-defined binary restenosis of the target lesion at 12 months, or at the time of re-intervention.

Not Provided
Not Provided
 
IN.PACT Global Clinical Study
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.
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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Arterial Disease
Device: IN.PACT Admiral™ Drug Eluting Balloon
IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1538
December 2020
April 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Belgium,   Canada,   Colombia,   Czech Republic,   Egypt,   Finland,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Korea, Republic of,   Lithuania,   Netherlands,   Poland,   Portugal,   Russian Federation,   Singapore,   Slovakia,   Slovenia,   Sweden,   Switzerland,   United Kingdom
 
NCT01609296
10048613
No
Not Provided
Not Provided
Medtronic Endovascular
Medtronic Endovascular
Not Provided
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
Medtronic Endovascular
June 2016

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