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IN.PACT Global Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01609296
Recruitment Status : Active, not recruiting
First Posted : May 31, 2012
Results First Posted : January 28, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Brief Summary:
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 or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: IN.PACT Admiral™ Drug Eluting Balloon Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1535 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : May 2012
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Primary Endpoint Clinical Cohort [ Time Frame: 12 months ]
    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.

  2. Primary Safety Endpoint [ Time Frame: 12 months ]
    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 :
  1. MAEs [ Time Frame: 12 months ]
    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.

  2. TLR [ Time Frame: 12 months ]
    Any Target lesion revascularisation

  3. TVR [ Time Frame: 12 months. ]
    Any Target vessel revascularisation

  4. Primary Sustained Clinical Improvement [ Time Frame: 12 months. ]
    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.

  5. Device Success [ Time Frame: Index-procedure ]
    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)

  6. Clinical Success [ Time Frame: prior to discharge ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609296


  Hide Study Locations
Locations
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Argentina
Fundación Favaloro
Buenos Aires, Argentina
Clinica La Sagrada Familia
Bueos Aires, Argentina
Australia
Royal Prince Alfred Hospital
Sydney, Australia, NSW 2050
Austria
Medizinische Universität Graz
Graz, Austria, 8036
Landesklinikum Thermenregion Mödling
Mödling, Austria, 2340
Belgium
Onze-Lieve-Vrouwziekenuis
Aalst, Belgium, 9300
Imelda Ziekenhuis
Bonheiden, Belgium, 2820
AZ St. Blasius
Dendermonde, Belgium, 9200
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Ziekenhuis Oost Limburg - Campus St.-Jan
Genk, Belgium, 3600
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Regionaal Ziekenhuis Heilig Hart
Tienen, Belgium, 3300
Canada
Centre hospitalier universitaire Sherbrooke (CHUS)
Sherbrooke, Canada
University Health Network (UHN)
Toronto, Canada
Colombia
Clinica Santa Maria
Medellin, Colombia
Clinica Medilaser Neiva
Neiva, Colombia
Czechia
Faculty Hospital Hradec Kralove
Hradec Kralove, Czechia, 50005
Egypt
As-Salam International Hospital
Cairo, Egypt
Egypt Air Hospital
Cairo, Egypt
Finland
Helsingin Seudun Yliopistollinen Keskussairaala
Helsinki, Finland
France
Group Hospitalier Pellegrin - CHU
Bordeaux Cedex, France, 33076
Les Hospitaux Universitaires de Strasbourg
Strasbourg, France, 67000
Germany
Herzzentrum Bad Krozingen
Bad Krozingen, Germany, 79189
Augusta-Krankenhaus
Duesseldorf, Germany
Augusta Krankenhaus
Düsseldorf, Germany, 40472
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Universitatsklinikum Leipzig AoR
Leipzig, Germany, 04103
Park-Krankenhaus Leipzig
Leipzig, Germany, 04289
St. Franziskus Hospital GmbH
Münster, Germany, 48145
RoMed Klinikum Rosenheim
Rosenheim, Germany, 83022
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Greece
University Hospital of Patras
Patra, Greece, TK26504
Hungary
Semmelweis University
Budapest, Hungary, 1122
Bacs Kiskun Megyei Korhaz
Kecskemét, Hungary, 6000
Israel
Carmel Medical Centre
Haifa, Israel, 34362
Rabin Medical Center - Beilison Hospital
Petach Tikva, Israel, 49100
Italy
Policlinico Vittorio Emanuele
Catania, Italy, 95123
Maria Eleonora Hospital
Palermo, Italy, 90135
Policlinico Gemelli
Rome, Italy, 00168
Korea, Republic of
Samsung Medical Center
Gangnam-gu, Seoul, Korea, Republic of, 135-710
Korea University Guro Hospital
Guro-gu, Seoul, Korea, Republic of, 152-703
Severence Hospital
Seodaemun-gu, Seoul, Korea, Republic of, 120-752
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Ajou University Hospital
Suwon, Korea, Republic of, 443-380
Lithuania
Kaunas Mecial University Clinic
Kaunas, Lithuania, 50009
Kaunas University Clinic
Kaunas, Lithuania
Netherlands
Jeroen Bosch Ziekenhuis
's Hertogenbosch, Netherlands, 5223GZ
Rijnstate Ziekenhuis
Arnhem, Netherlands, 6800TA
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623EJ
Sint Antonius Hospital
Nieuwegein, Netherlands, 3430EM
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584CX
Poland
Euromedic Medical Center
Katowice, Poland, 40-519
Samodzielny Publiczny Szpital Kliniczny Nr 2
Szczecin, Poland, 70-111
Portugal
Hospital Santa Marta
Lisbon, Portugal, 1169-024
Russian Federation
42115 - City Hospital # 71
Moscow, Russian Federation, 121374
Singapore
Changi General Hospital
Singapore, Singapore, 529889
Slovakia
Stredoslovensky ustav srdcovych a cievnych chorob (SUSCCH)
Banská Bystrica, Slovakia, 97401
SUSCCH, a.s., Banska Bystrica
Banská Bystrica, Slovakia
Národný ústav srdcových a cievnych chorôb a.s. (NUSCH)
Bratislava, Slovakia, 83348
Východoslovenský ústav srdcových a cievnych chorôb, a.s.(VUSH)
Kosice, Slovakia, 04011
Slovenia
University Medical Centre Maribor
Maribor, Slovenia, 2000
University Medical Centre Maribor
Maribor, Slovenia
Sweden
Karolinska Universitetssjukhuset
Solna, Sweden, 17176
Switzerland
Inselspital - Universitätsspial Bern
Bern, Switzerland, 3010
Hopital Cantonal HFR
Fribourg, Switzerland, 1708
Kantonspital Luzern
Luzern, Switzerland, 6000
United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom, M139WL
Northern General Hospital
Sheffield, United Kingdom, S57AU
Sponsors and Collaborators
Medtronic Endovascular
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01609296     History of Changes
Other Study ID Numbers: 10048613
First Posted: May 31, 2012    Key Record Dates
Results First Posted: January 28, 2019
Last Update Posted: February 15, 2019
Last Verified: February 2019

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

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