IN.PACT Global Clinical Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Medtronic Endovascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01609296
First received: May 24, 2012
Last updated: July 23, 2014
Last verified: July 2014

May 24, 2012
July 23, 2014
May 2012
February 2019   (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.
  • 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.
Same as current
Complete list of historical versions of study NCT01609296 on ClinicalTrials.gov Archive Site
  • 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 (Target Vessel Revascularization), 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.

  • 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.

150mm cohort [ Time Frame: All primary and co-secondary study endpoints as described above will be assessed for this group of subjects separately. ] [ Designated as safety issue: No ]
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: INPACT 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) 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.
 
Recruiting
1500
December 2019
February 2019   (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
No
Contact: Randy Schmahl, LLM, MSc +31 43 3566 697 randy.schmahl@medtronic.com
Contact: Reka Dobranszki +31 43 3566 641 reka.dobranszki@gmail.com
Argentina,   Belgium,   Canada,   Colombia,   Czech Republic,   Egypt,   Finland,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Lithuania,   Netherlands,   Poland,   Portugal,   Russian Federation,   Singapore,   Slovakia,   Slovenia,   Switzerland
 
NCT01609296
10048613
No
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
July 2014

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