IN.PACT Global Clinical Study

This study is currently recruiting participants.
Verified January 2014 by Medtronic Endovascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01609296
First received: May 24, 2012
Last updated: February 13, 2014
Last verified: January 2014
  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.

  • 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.


Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 1500
Study Start Date: May 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609296

Contacts
Contact: Randy Schmahl, LLM, MSc +31 43 3566 697 randy.schmahl@medtronic.com
Contact: Niels Boon, PhD +31 43 3566 822 niels.boon@medtronic.com

  Hide Study Locations
Locations
Argentina
Fundación Favaloro Recruiting
Buenos Aires, Argentina
Contact: Oscar Mendiz       omendiz@ffavaloro.org   
Principal Investigator: Oscar Mendiz         
Hospital Clínica La Sagrada Familia Recruiting
Buenos Aires, Argentina
Contact: Luis Ferreira       drferreira@yahoo.com   
Principal Investigator: Luis Ferreira         
Clinica La Sagrada Familia Recruiting
Bueos Aires, Argentina
Contact: Luis Ferreira       drferreira@yahoo.com   
Principal Investigator: Luis Ferreira         
Belgium
Onze-Lieve-Vrouwziekenuis Recruiting
Aalst, Belgium, 9300
Contact: Lieven Maene       lieven.maene@olvz-aalst.be   
Principal Investigator: Lieven Maene         
Imelda Ziekenhuis Recruiting
Bonheiden, Belgium, 2820
Contact: Patrick Peeters       patrick.peeters@imelda.be   
Principal Investigator: Patrick Peeters         
AZ St. Blasius Recruiting
Dendermonde, Belgium, 9200
Contact: Marc Bosiers       marc.bosiers@telenet.be   
Principal Investigator: Marc Bosiers         
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium, 2650
Contact: Jeroen Hendriks       jeroen.hendriks@uza.be   
Principal Investigator: Jeroen Hendriks         
Ziekenhuis Oost Limburg - Campus St.-Jan Recruiting
Genk, Belgium, 3600
Contact: Wouter Lansink       wouter.lansink@zol.be   
Principal Investigator: Wouter Lansink         
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
Contact: Frank Vermassen       frank.vermassen@ugent.be   
Principal Investigator: Frank Vermassen         
Regionaal Ziekenhuis Heilig Hart Recruiting
Tienen, Belgium, 3300
Contact: Koen Keirse       koen.keirse@rztienen.be   
Principal Investigator: Koen Keirse         
Canada
Centre hospitalier universitaire Sherbrooke (CHUS) Recruiting
Sherbrooke, Canada
Contact: Andrew Benko       andrew.j.benko@usherbrooke.ca   
Principal Investigator: Andrew Benko         
University Health Network (UHN) Recruiting
Toronto, Canada
Contact: Kong Teng Tan       kongteng.tan@uhn.on.ca   
Principal Investigator: Kongteng Tan         
Colombia
Clinica Santa Maria Recruiting
Medellin, Colombia
Contact: Juan Fernando Gomez       jfgomezh@une.net.com   
Principal Investigator: Juan Fernando Gomez         
Clinica Medilaser Neiva Recruiting
Neiva, Colombia
Contact: Cesar Cuellar       cecuellarc@gmail.com   
Principal Investigator: Cesar Cuellar         
Czech Republic
Faculty Hospital Hradec Kralove Recruiting
Hradec Kralove, Czech Republic, 50005
Contact: Radovan Maly       radovan.maly@fnhk.cz   
Principal Investigator: Radovan Maly         
Egypt
As-Salam International Hospital Recruiting
Cairo, Egypt
Contact: Hossam Mansour       mansour.hossam@gmail.com   
Principal Investigator: Hossam Mansour         
Egypt Air Hospital Recruiting
Cairo, Egypt
Contact: Mamdouh Labib       dr.labib@link.net   
Principal Investigator: Mamdouh Labib         
Finland
Helsingin Seudun Yliopistollinen Keskussairaala Recruiting
Helsinki, Finland
Contact: Maarit Venermo       maarit.venermo@hus.fi   
Principal Investigator: Maarit Venermo         
Germany
Herzzentrum Bad Krozingen Recruiting
Bad Krozingen, Germany, 79189
Contact: Thomas Zeller       thomas.zeller@herzzentrum.de   
Principal Investigator: Thomas Zeller         
Augusta-Krankenhaus Recruiting
Duesseldorf, Germany
Contact: Ralf Kolvenbach       ralf.kolvenbach@vkkd-kliniken.de   
Principal Investigator: Ralf Kolvenbach         
Augusta Krankenhaus Active, not recruiting
Düsseldorf, Germany, 40472
Medizinische Universität Graz Recruiting
Gratz, Germany, 8036
Contact: Ernst Pilger       ernst.pilger@medunigraz.at   
Principal Investigator: Ernst Pilger         
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Erwin Blessing       erwin.blessing@med.uni-heidelberg.de   
Principal Investigator: Erwin Blessing         
Park-Krankenhaus Leipzig Recruiting
Leipzig, Germany, 04289
Contact: Dierk Scheinert       dierk.scheinert@parkkrankenhaus-leipzig.de   
Principal Investigator: Dierk Scheinert         
Landesklinikum Thermenregion Mödling Recruiting
Mödling, Germany, 2340
Contact: Franz Roithinger       franz.roithinger@moedling.lknoe.at   
Principal Investigator: Franz Roithinger         
Principal Investigator: Marianne Brodmann         
St. Franziskus Hospital GmbH Recruiting
Münster, Germany, 48145
Contact: Giovanni Torsello       giovanni.torsello@sfh-muenster.de   
Principal Investigator: Giovanni Torsello         
RoMed Klinikum Rosenheim Recruiting
Rosenheim, Germany, 83022
Contact: Gunnar Tepe       gunnar.tepe@ro-med.de   
Principal Investigator: Gunnar Tepe         
Universitätsklinikum Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Klaus Brechtel       klaus.brechtel@med.uni-tuebingen.de   
Principal Investigator: Klaus Brechtel         
Hungary
Semmelweis University Recruiting
Budapest, Hungary, 1122
Contact: Bela Merkely       merkely.bela@kardio.sote.hu   
Principal Investigator: Bela Merkely         
Sub-Investigator: Balazs Nemes         
Bacs Kiskun Megyei Korhaz Recruiting
Kecskemét, Hungary, 6000
Contact: Zoltan Ruzsa       zruzsa25@gmail.com   
Principal Investigator: Zoltan Ruzsa         
Israel
Carmel Medical Centre Recruiting
Haifa, Israel
Contact: Dalit Mannheim       dalitma@clalit.org   
Principal Investigator: Dalit Mannheim         
Carmel Medical Centre Recruiting
Haifa, Israel, 34362
Contact: Dalit Mannheim       dalitma@clalit.org.il   
Principal Investigator: Dalit Mannheim         
Rabin Medical Center - Beilison Hospital Recruiting
Petach Tikva, Israel, 49100
Contact: Alexander Belenky       alexanderb@clalit.org.il   
Principal Investigator: Alexander Belenky         
Assaf Harofeh Medical Center Recruiting
Tel Aviv, Israel
Contact: Eitan Heldenberg       eitan@heldenberg.co.il   
Principal Investigator: Eitan Heldenberg         
Italy
S. Orsola Hospital Active, not recruiting
Bologna, Italy, 40138
Osp. S.Orsola Recruiting
Bologna, Italy
Contact: Andrea Stella       andrea.stella2@unibo.it   
Principal Investigator: Andrea Stella         
Policlinico Vittorio Emanuele Recruiting
Catania, Italy, 95123
Contact: Pierfrancesco Veroux       pveroux@unict.it   
Principal Investigator: Pierfrancesco Veroux         
Villa Maria Eleonora Hospital Recruiting
Palermo, Italy, 90135
Contact: Antonio Micari       micariantonio@gmail.com   
Principal Investigator: Antonio Micari         
Policlinico Gemelli Recruiting
Rome, Italy, 00168
Contact: Carlo Trani       carlotrani@gmail.com   
Principal Investigator: Carlo Trani         
Ospedale Mauriziano Recruiting
Torino, Italy
Contact: Franco Nessi       fnessi@mauriziano.it   
Principal Investigator: Franco Nessi         
Korea, Republic of
Samsung Medical Center Recruiting
Gangnam-gu, Seoul, Korea, Republic of, 135-710
Contact: Young-Soo Do       ysdo@skku.edu   
Principal Investigator: Young-Soo Do         
Korea University Guro Hospital Recruiting
Guro-gu, Seoul, Korea, Republic of, 152-703
Contact: Seung-Whoon Rha       swrha617@yahoo.co.kr   
Principal Investigator: Seung-Woon Rha         
Severence Hospital Recruiting
Seodaemun-gu, Seoul, Korea, Republic of, 120-752
Contact: Donghoon Choi       cdhlyj@yuhs.ac   
Principal Investigator: Donghoon Choi         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Seung-Whan Lee       seungwlee@amc.seoul.kr   
Principal Investigator: Seung-Whan Lee         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-Whan Lee       seungwlee@amc.seoul.kr   
Principal Investigator: Seung-Whan Lee         
Ajou University Hospital Recruiting
Suwon, Korea, Republic of, 443-380
Contact: Je Hwan Won       wonkwak@ajou.ac.kr   
Principal Investigator: Je Hwan Won         
Lithuania
Kaunas Mecial University Clinic Active, not recruiting
Kaunas, Lithuania, 50009
Kaunas University Clinic Recruiting
Kaunas, Lithuania
Contact: Linas Velicka       lvelicka@gmail.com   
Principal Investigator: Linas Velicka         
Netherlands
Rijnstate Ziekenhuis Recruiting
Arnhem, Netherlands, 6800TA
Contact: Jan Willem Lardenoije       jlardenoije@rijnstate.nl   
Principal Investigator: Jan Willem Lardenoije         
Catharina Ziekenhuis Recruiting
Eindhoven, Netherlands, 5623EJ
Contact: Joep Teijink       joep.teijink@catharinaziekenhuis.nl   
Principal Investigator: Joep Teijink         
Sint Antonius Hospital Recruiting
Nieuwegein, Netherlands, 3430EM
Contact: Jean-Paul de Vries       j.vries@antoniusziekenhuis.nl   
Principal Investigator: Jean-Paul de Vries         
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands, 3584CX
Contact: Gert Jan de Borst       g.j.deborst-2@umcutrecht.nl   
Principal Investigator: Gert Jan de Borst         
University Medical Centre Utrecht Recruiting
Utrecht, Netherlands
Contact: Gert Jan de Borst       g.j.deborst-2@umcutrecht.nl   
Principal Investigator: Gert Jan de Borst         
Poland
Euromedic Medical Center Recruiting
Katowice, Poland, 40-519
Contact: Thomasz Ludyga       t.ludyga@poczta.fm   
Principal Investigator: Thomasz Ludyga         
Portugal
Hospital Santa Marta Recruiting
Lisbon, Portugal, 1169-024
Contact: João Albuquerque e Castro       albucastro@gmail.com   
Principal Investigator: João Albuquerque e Castro         
Russian Federation
Scientific Center of Endocrinology Not yet recruiting
Moscow, Russian Federation, 117036
Contact: Gagik Galstyan       mariagrishina@yandex.ru   
Principal Investigator: Gagik Galstyan         
Singapore
Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: Steven Kum       Steven_kum@cgh.com.sg   
Principal Investigator: Steven Kum         
Slovakia
SUSCCH, a.s., Banska Bystrica Recruiting
Banska, Slovakia
Contact: Matej Vozar       vozar.matej@suscch.eu   
Principal Investigator: Matej Vozar         
Stredoslovensky ustav srdcovych a cievnych chorob (SUSCCH) Recruiting
Banská Bystrica, Slovakia, 97401
Contact: Matej Vozar       vozar.matej@suscch.eu   
Principal Investigator: Matej Vozar         
Národný ústav srdcových a cievnych chorôb a.s. (NUSCH) Recruiting
Bratislava, Slovakia, 83348
Contact: Ivan Vulev       ivan.vulev@nusch.sk   
Principal Investigator: Ivan Vulev         
Východoslovenský ústav srdcových a cievnych chorôb, a.s.(VUSH) Recruiting
Kosice, Slovakia, 04011
Contact: Lubomir Spak       lubospak@hotmail.com   
Principal Investigator: Lubomir Spak         
Slovenia
University Medical Centre Maribor Recruiting
Maribor, Slovenia, 2000
Contact: Jozef Matela       matela@ukc-mb.si   
Principal Investigator: Jozef Matela         
University Medical Centre Maribor Recruiting
Maribor, Slovenia
Contact: Jozef Matela       matela@ukc-mb.si   
Principal Investigator: Jozef Matela         
Switzerland
Inselspital - Universitätsspial Bern Recruiting
Bern, Switzerland, 3010
Contact: Dai-Do Do       dai-do.do@insel.ch   
Principal Investigator: Dai-Do Do         
Hopital Cantonal HFR Recruiting
Fribourg, Switzerland, 1708
Contact: Daniel Periard       periardd@h-fr.ch   
Principal Investigator: Daniel Periard         
Kantonspital Luzern Recruiting
Luzern, Switzerland, 6000
Contact: Martin Banyai       martin.banyai@luks.ch   
Principal Investigator: Martin Banyai         
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

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01609296     History of Changes
Other Study ID Numbers: 10048613
Study First Received: May 24, 2012
Last Updated: February 13, 2014
Health Authority: Argentina: Human Research Bioethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Ethikkommission
Belgium: Ethics Committee
Brazil: ANVISA
Canada: Health Canada
Canada: Ministère santé et services sociaux du Québec
Colombia: Ethics Committee
Czech Republic: Ethics Committee
Egypt: Institutional Review Board
France: Conseil National de l'Ordre des Médecins
Germany: Ethics Commission
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: Ethics Committee
Slovenia: Ethics Committee
Spain: Ethics Committee
Sweden: Institutional Review Board
Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee

Keywords provided by Medtronic Endovascular:
Peripheral Arterial Disease
Drug eluting 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 April 14, 2014