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
  Purpose
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 Intervention Phase
Peripheral Arterial Disease
Device: IN.PACT Admiral™ Drug Eluting Balloon
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1538
Study Start Date: May 2012
Estimated Study Completion Date: December 2020
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609296

  Show 68 Study Locations
Sponsors and Collaborators
Medtronic Endovascular
Investigators
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
  More Information

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01609296     History of Changes
Other Study ID Numbers: 10048613 
Study First Received: May 24, 2012
Last Updated: June 17, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Ethikkommission
Belgium: Ethics Committee
Canada: Health Canada
Canada: Ministère santé et services sociaux du Québec
Colombia: Ethics Committee
Czech Republic: Ethics Committee
Egypt: Institutional Review Board
Finland: Ethics Committee
Germany: Ethics Commission
Greece: Ethics Committee
Hungary: Institutional Ethics Committee
Israel: Ethics Commission
Italy: Ethics Committee
Korea: Institutional Review Board
Lithuania: Bioethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Poland: Ethics Committee
Portugal: Ethics Committee for Clinical Research
Russia: Ethics Committee
Singapore: Ministry of Health
Slovakia: Central Ethics Committee - Rozhodnutie Cenralnej etickej komisie
Slovenia: Ethics Committee
Sweden: Institutional Review Board
Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee
Argentina: Human Research Bioethics Committee

Keywords provided by Medtronic Endovascular:
Peripheral Arterial Disease
Drug coated balloon
Superficial Femoral Artery
Popliteal Femoral Artery
Atherosclerosis

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2016