IN.PACT Global Clinical Study

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

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.

Other Outcome Measures:
  • 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 ]

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01609296

Contact: Randy Schmahl, LLM, MSc +31 43 3566 697
Contact: Reka Dobranszki +31 43 3566 641

  Hide Study Locations
Fundación Favaloro Recruiting
Buenos Aires, Argentina
Contact: Oscar Mendiz   
Principal Investigator: Oscar Mendiz         
Hospital Clínica La Sagrada Familia Recruiting
Buenos Aires, Argentina
Contact: Luis Ferreira   
Principal Investigator: Luis Ferreira         
Clinica La Sagrada Familia Recruiting
Bueos Aires, Argentina
Contact: Luis Ferreira   
Principal Investigator: Luis Ferreira         
Onze-Lieve-Vrouwziekenuis Recruiting
Aalst, Belgium, 9300
Contact: Lieven Maene   
Principal Investigator: Lieven Maene         
Imelda Ziekenhuis Recruiting
Bonheiden, Belgium, 2820
Contact: Patrick Peeters   
Principal Investigator: Patrick Peeters         
AZ St. Blasius Recruiting
Dendermonde, Belgium, 9200
Contact: Marc Bosiers   
Principal Investigator: Marc Bosiers         
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium, 2650
Contact: Jeroen Hendriks   
Principal Investigator: Jeroen Hendriks         
Ziekenhuis Oost Limburg - Campus St.-Jan Recruiting
Genk, Belgium, 3600
Contact: Wouter Lansink   
Principal Investigator: Wouter Lansink         
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
Contact: Frank Vermassen   
Principal Investigator: Frank Vermassen         
Regionaal Ziekenhuis Heilig Hart Recruiting
Tienen, Belgium, 3300
Contact: Koen Keirse   
Principal Investigator: Koen Keirse         
Centre hospitalier universitaire Sherbrooke (CHUS) Recruiting
Sherbrooke, Canada
Contact: Andrew Benko   
Principal Investigator: Andrew Benko         
University Health Network (UHN) Recruiting
Toronto, Canada
Contact: Kong Teng Tan   
Principal Investigator: Kongteng Tan         
Clinica Santa Maria Recruiting
Medellin, Colombia
Contact: Juan Fernando Gomez   
Principal Investigator: Juan Fernando Gomez         
Clinica Medilaser Neiva Recruiting
Neiva, Colombia
Contact: Cesar Cuellar   
Principal Investigator: Cesar Cuellar         
Czech Republic
Faculty Hospital Hradec Kralove Recruiting
Hradec Kralove, Czech Republic, 50005
Contact: Radovan Maly   
Principal Investigator: Radovan Maly         
As-Salam International Hospital Recruiting
Cairo, Egypt
Contact: Hossam Mansour   
Principal Investigator: Hossam Mansour         
Egypt Air Hospital Recruiting
Cairo, Egypt
Contact: Mamdouh Labib   
Principal Investigator: Mamdouh Labib         
Helsingin Seudun Yliopistollinen Keskussairaala Recruiting
Helsinki, Finland
Contact: Maarit Venermo   
Principal Investigator: Maarit Venermo         
Herzzentrum Bad Krozingen Recruiting
Bad Krozingen, Germany, 79189
Contact: Thomas Zeller   
Principal Investigator: Thomas Zeller         
Augusta-Krankenhaus Recruiting
Duesseldorf, Germany
Contact: Ralf Kolvenbach   
Principal Investigator: Ralf Kolvenbach         
Augusta Krankenhaus Active, not recruiting
Düsseldorf, Germany, 40472
Medizinische Universität Graz Recruiting
Gratz, Germany, 8036
Contact: Ernst Pilger   
Principal Investigator: Ernst Pilger         
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Erwin Blessing   
Principal Investigator: Erwin Blessing         
Park-Krankenhaus Leipzig Recruiting
Leipzig, Germany, 04289
Contact: Dierk Scheinert   
Principal Investigator: Dierk Scheinert         
Landesklinikum Thermenregion Mödling Recruiting
Mödling, Germany, 2340
Contact: Franz Roithinger   
Principal Investigator: Franz Roithinger         
Principal Investigator: Marianne Brodmann         
St. Franziskus Hospital GmbH Recruiting
Münster, Germany, 48145
Contact: Giovanni Torsello   
Principal Investigator: Giovanni Torsello         
RoMed Klinikum Rosenheim Recruiting
Rosenheim, Germany, 83022
Contact: Gunnar Tepe   
Principal Investigator: Gunnar Tepe         
Universitätsklinikum Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Klaus Brechtel   
Principal Investigator: Klaus Brechtel         
Semmelweis University Recruiting
Budapest, Hungary, 1122
Contact: Bela Merkely   
Principal Investigator: Bela Merkely         
Sub-Investigator: Balazs Nemes         
Bacs Kiskun Megyei Korhaz Recruiting
Kecskemét, Hungary, 6000
Contact: Zoltan Ruzsa   
Principal Investigator: Zoltan Ruzsa         
Carmel Medical Centre Recruiting
Haifa, Israel
Contact: Dalit Mannheim   
Principal Investigator: Dalit Mannheim         
Carmel Medical Centre Recruiting
Haifa, Israel, 34362
Contact: Dalit Mannheim   
Principal Investigator: Dalit Mannheim         
Rabin Medical Center - Beilison Hospital Recruiting
Petach Tikva, Israel, 49100
Contact: Alexander Belenky   
Principal Investigator: Alexander Belenky         
Assaf Harofeh Medical Center Recruiting
Tel Aviv, Israel
Contact: Eitan Heldenberg   
Principal Investigator: Eitan Heldenberg         
S. Orsola Hospital Active, not recruiting
Bologna, Italy, 40138
Osp. S.Orsola Recruiting
Bologna, Italy
Contact: Andrea Stella   
Principal Investigator: Andrea Stella         
Policlinico Vittorio Emanuele Recruiting
Catania, Italy, 95123
Contact: Pierfrancesco Veroux   
Principal Investigator: Pierfrancesco Veroux         
Villa Maria Eleonora Hospital Recruiting
Palermo, Italy, 90135
Contact: Antonio Micari   
Principal Investigator: Antonio Micari         
Policlinico Gemelli Recruiting
Rome, Italy, 00168
Contact: Carlo Trani   
Principal Investigator: Carlo Trani         
Ospedale Mauriziano Recruiting
Torino, Italy
Contact: Franco Nessi   
Principal Investigator: Franco Nessi         
Korea, Republic of
Samsung Medical Center Recruiting
Gangnam-gu, Seoul, Korea, Republic of, 135-710
Contact: Young-Soo Do   
Principal Investigator: Young-Soo Do         
Korea University Guro Hospital Recruiting
Guro-gu, Seoul, Korea, Republic of, 152-703
Contact: Seung-Whoon Rha   
Principal Investigator: Seung-Woon Rha         
Severence Hospital Recruiting
Seodaemun-gu, Seoul, Korea, Republic of, 120-752
Contact: Donghoon Choi   
Principal Investigator: Donghoon Choi         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Seung-Whan Lee   
Principal Investigator: Seung-Whan Lee         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-Whan Lee   
Principal Investigator: Seung-Whan Lee         
Ajou University Hospital Recruiting
Suwon, Korea, Republic of, 443-380
Contact: Je Hwan Won   
Principal Investigator: Je Hwan Won         
Kaunas Mecial University Clinic Active, not recruiting
Kaunas, Lithuania, 50009
Kaunas University Clinic Recruiting
Kaunas, Lithuania
Contact: Linas Velicka   
Principal Investigator: Linas Velicka         
Rijnstate Ziekenhuis Recruiting
Arnhem, Netherlands, 6800TA
Contact: Jan Willem Lardenoije   
Principal Investigator: Jan Willem Lardenoije         
Catharina Ziekenhuis Recruiting
Eindhoven, Netherlands, 5623EJ
Contact: Joep Teijink   
Principal Investigator: Joep Teijink         
Sint Antonius Hospital Recruiting
Nieuwegein, Netherlands, 3430EM
Contact: Jean-Paul de Vries   
Principal Investigator: Jean-Paul de Vries         
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands, 3584CX
Contact: Gert Jan de Borst   
Principal Investigator: Gert Jan de Borst         
University Medical Centre Utrecht Recruiting
Utrecht, Netherlands
Contact: Gert Jan de Borst   
Principal Investigator: Gert Jan de Borst         
Euromedic Medical Center Recruiting
Katowice, Poland, 40-519
Contact: Thomasz Ludyga   
Principal Investigator: Thomasz Ludyga         
Hospital Santa Marta Recruiting
Lisbon, Portugal, 1169-024
Contact: João Albuquerque e Castro   
Principal Investigator: João Albuquerque e Castro         
Russian Federation
Scientific Center of Endocrinology Not yet recruiting
Moscow, Russian Federation, 117036
Contact: Gagik Galstyan   
Principal Investigator: Gagik Galstyan         
Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: Steven Kum   
Principal Investigator: Steven Kum         
SUSCCH, a.s., Banska Bystrica Recruiting
Banska, Slovakia
Contact: Matej Vozar   
Principal Investigator: Matej Vozar         
Stredoslovensky ustav srdcovych a cievnych chorob (SUSCCH) Recruiting
Banská Bystrica, Slovakia, 97401
Contact: Matej Vozar   
Principal Investigator: Matej Vozar         
Národný ústav srdcových a cievnych chorôb a.s. (NUSCH) Recruiting
Bratislava, Slovakia, 83348
Contact: Ivan Vulev   
Principal Investigator: Ivan Vulev         
Východoslovenský ústav srdcových a cievnych chorôb, a.s.(VUSH) Recruiting
Kosice, Slovakia, 04011
Contact: Lubomir Spak   
Principal Investigator: Lubomir Spak         
University Medical Centre Maribor Recruiting
Maribor, Slovenia, 2000
Contact: Jozef Matela   
Principal Investigator: Jozef Matela         
University Medical Centre Maribor Recruiting
Maribor, Slovenia
Contact: Jozef Matela   
Principal Investigator: Jozef Matela         
Inselspital - Universitätsspial Bern Recruiting
Bern, Switzerland, 3010
Contact: Dai-Do Do   
Principal Investigator: Dai-Do Do         
Hopital Cantonal HFR Recruiting
Fribourg, Switzerland, 1708
Contact: Daniel Periard   
Principal Investigator: Daniel Periard         
Kantonspital Luzern Recruiting
Luzern, Switzerland, 6000
Contact: Martin Banyai   
Principal Investigator: Martin Banyai         
Sponsors and Collaborators
Medtronic Endovascular
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 Identifier: NCT01609296     History of Changes
Other Study ID Numbers: 10048613
Study First Received: May 24, 2012
Last Updated: July 23, 2014
Health Authority: Argentina: Human Research Bioethics Committee
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

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

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on September 18, 2014