IN.PACT Global Clinical Study

NCT01609296 | Completed Results

• 1 other identifier: 10048613
• Study Type: interventional
• Target: 1,535
• Locations: 25 countries
• Sites: 60

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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; Drug coated balloon; Superficial Femoral Artery; Popliteal Femoral Artery; Atherosclerosis; Drug eluting balloon

Outcome Measures

Primary Outcomes (4)

• Clinical Cohort ITT - Primary Effectiveness Endpoint

  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.

  12 months

• Clinical Cohort ITT - Primary Safety Endpoint

  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.

  12 months

• Imaging Cohort ITT - Primary Effectiveness Endpoint

  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.

  12 months

• 150mm DEB ITT Cohort - Primary Effectiveness Endpoint

  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.

  12 months

Secondary Outcomes (146)

• Clinical Cohort ITT - MAEs

  12 months

• Clinical Cohort ITT - TLR

  12 months

• Clinical Cohort ITT - TVR

  12 months.

• Clinical Cohort ITT - Device Success

  Index-procedure

• Clinical Cohort ITT - Clinical Success

  prior to discharge

Study Arms (1)

IN.PACT Admiral DEB

EXPERIMENTAL

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

Interventions

IN.PACT Admiral™ Drug Eluting Balloon DEVICE

IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.

IN.PACT Admiral DEB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (65)

Fundación Favaloro

Buenos Aires, Argentina

Location

Clinica La Sagrada Familia

Bueos Aires, Argentina

Location

Royal Prince Alfred Hospital

Sydney, NSW 2050, Australia

Location

Medizinische Universität Graz

Graz, 8036, Austria

Location

Landesklinikum Thermenregion Mödling

Mödling, 2340, Austria

Location

Onze-Lieve-Vrouwziekenuis

Aalst, 9300, Belgium

Location

Imelda Ziekenhuis

Bonheiden, 2820, Belgium

Location

AZ St. Blasius

Dendermonde, 9200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Ziekenhuis Oost Limburg - Campus St.-Jan

Genk, 3600, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Regionaal Ziekenhuis Heilig Hart

Tienen, 3300, Belgium

Location

Centre hospitalier universitaire Sherbrooke (CHUS)

Sherbrooke, Canada

Location

Toronto General Hospital

Toronto, Canada

Location

Clinica Santa Maria

Medellín, Colombia

Location

Clinica Medilaser Neiva

Neiva, Colombia

Location

Faculty Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

As-Salam International Hospital

Cairo, Egypt

Location

Egypt Air Hospital

Cairo, Egypt

Location

Helsingin Seudun Yliopistollinen Keskussairaala

Helsinki, Finland

Location

Group Hospitalier Pellegrin - CHU

Bordeaux, 33076, France

Location

Les Hospitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location

Herzzentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Augusta Krankenhaus

Düsseldorf, 40472, Germany

Location

Augusta-Krankenhaus

Düsseldorf, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitatsklinikum Leipzig AoR

Leipzig, 04103, Germany

Location

Park-Krankenhaus Leipzig

Leipzig, 04289, Germany

Location

St. Franziskus Hospital GmbH

Münster, 48145, Germany

Location

RoMed Klinikum Rosenheim

Rosenheim, 83022, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

University Hospital of Patras

Pátrai, TK26504, Greece

Location

Semmelweis University

Budapest, 1122, Hungary

Location

Bacs Kiskun Megyei Korhaz

Kecskemét, 6000, Hungary

Location

Carmel Medical Centre

Haifa, 34362, Israel

Location

Rabin Medical Center - Beilison Hospital

Petah Tikva, 49100, Israel

Location

Policlinico Vittorio Emanuele

Catania, 95123, Italy

Location

Maria Eleonora Hospital

Palermo, 90135, Italy

Location

Policlinico Gemelli

Rome, 00168, Italy

Location

Kaunas Mecial University Clinic

Kaunas, 50009, Lithuania

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5223GZ, Netherlands

Location

Rijnstate Ziekenhuis

Arnhem, 6800TA, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5623EJ, Netherlands

Location

Sint Antonius Hospital

Nieuwegein, 3430EM, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3584CX, Netherlands

Location

Euromedic Medical Center

Katowice, 40-519, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 2

Szczecin, 70-111, Poland

Location

Hospital Santa Marta

Lisbon, 1169-024, Portugal

Location

City Clinical Hospital named after M.E. Zhadkevich

Moscow, 121374, Russia

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

Stredoslovensky ustav srdcovych a cievnych chorob (SUSCCH)

Banská Bystrica, 97401, Slovakia

Location

Národný ústav srdcových a cievnych chorôb a.s. (NUSCH)

Bratislava, 83348, Slovakia

Location

Východoslovenský ústav srdcových a cievnych chorôb, a.s.(VUSH)

Košice, 04011, Slovakia

Location

University Medical Centre Maribor

Maribor, 2000, Slovenia

Location

Severence Hospital

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Ajou University Hospital

Suwon, 443-380, South Korea

Location

Karolinska Universitetssjukhuset

Solna, 17176, Sweden

Location

Inselspital - Universitätsspial Bern

Bern, 3010, Switzerland

Location

Hopital Cantonal HFR

Fribourg, 1708, Switzerland

Location

Kantonspital Luzern

Lucerne, 6000, Switzerland

Location

Manchester Royal Infirmary

Manchester, M139WL, United Kingdom

Location

Northern General Hospital

Sheffield, S57AU, United Kingdom

Location

Related Publications (14)

• Ansel GM, Brodmann M, Rocha-Singh KJ, Menk JS, Zeller T; IN.PACT Global Study Investigators. Five-Year Safety and Effectiveness of Paclitaxel Drug-Coated Balloons Alone or With Provisional Bare Metal Stenting for Real-World Femoropopliteal Lesions: IN.PACT Global Study Subgroup Analysis. Circ Cardiovasc Interv. 2024 Feb;17(2):e013084. doi: 10.1161/CIRCINTERVENTIONS.123.013084. Epub 2024 Feb 13.

  PMID: 38348677 DERIVED

• Krishnan P, Farhan S, Schneider P, Kamran H, Iida O, Brodmann M, Micari A, Sachar R, Urasawa K, Scheinert D, Ando K, Tarricone A, Doros G, Tepe G, Yokoi H, Laird J, Zeller T. Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. J Am Coll Cardiol. 2022 Sep 27;80(13):1241-1250. doi: 10.1016/j.jacc.2022.06.043.

  PMID: 36137674 DERIVED

• Brodmann M, Lansink W, Guetl K, Micari A, Menk J, Zeller T. Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study. Cardiovasc Intervent Radiol. 2022 Sep;45(9):1276-1287. doi: 10.1007/s00270-022-03214-y. Epub 2022 Jul 21.

  PMID: 35864209 DERIVED

• Zeller T, Brodmann M, Ansel GM, Scheinert D, Choi D, Tepe G, Menk J, Micari A. Paclitaxel-coated balloons for femoropopliteal peripheral arterial disease: final five-year results of the IN.PACT Global Study. EuroIntervention. 2022 Dec 2;18(11):e940-e948. doi: 10.4244/EIJ-D-21-01098.

  PMID: 35635160 DERIVED

• Torsello G, Stavroulakis K, Brodmann M, Micari A, Tepe G, Veroux P, Benko A, Choi D, Vermassen FEG, Jaff MR, Guo J, Dobranszki R, Zeller T; IN.PACT Global Investigators. Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort. J Endovasc Ther. 2020 Oct;27(5):693-705. doi: 10.1177/1526602820931477. Epub 2020 Jun 25.

  PMID: 32583749 DERIVED

• Shishehbor MH, Schneider PA, Zeller T, Razavi MK, Laird JR, Wang H, Tieche C, Parikh SA, Iida O, Jaff MR. Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts. J Vasc Surg. 2019 Oct;70(4):1177-1191.e9. doi: 10.1016/j.jvs.2019.02.030.

  PMID: 31543165 DERIVED

• Reijnen MMPJ, van Wijck I, Zeller T, Micari A, Veroux P, Keirse K, Lee SW, Li P, Voulgaraki D, Holewijn S. Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study. J Endovasc Ther. 2019 Jun;26(3):305-315. doi: 10.1177/1526602819839044. Epub 2019 Apr 1.

  PMID: 30931726 DERIVED

• Tepe G, Micari A, Keirse K, Zeller T, Scheinert D, Li P, Schmahl R, Jaff MR; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):484-493. doi: 10.1016/j.jcin.2018.12.004.

  PMID: 30846089 DERIVED

• Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. 2019 May 28;73(20):2550-2563. doi: 10.1016/j.jacc.2019.01.013. Epub 2019 Jan 25.

  PMID: 30690141 DERIVED

• Zeller T, Brodmann M, Micari A, Keirse K, Peeters P, Tepe G, Scheinert D, Jaff MR, Rocha-Singh KJ, Li P, Schmahl R, Ansel GM; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain. Circ Cardiovasc Interv. 2019 Jan;12(1):e007730. doi: 10.1161/CIRCINTERVENTIONS.118.007730. No abstract available.

  PMID: 30630355 DERIVED

• Banerjee S, Khalili H. Drug-Coated Balloon for Long Femoropopliteal Lesions. Circ Cardiovasc Interv. 2018 Oct;11(10):e007084. doi: 10.1161/CIRCINTERVENTIONS.118.007084. No abstract available.

  PMID: 30354645 DERIVED

• Scheinert D, Micari A, Brodmann M, Tepe G, Peeters P, Jaff MR, Wang H, Schmahl R, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease. Circ Cardiovasc Interv. 2018 Oct;11(10):e005654. doi: 10.1161/CIRCINTERVENTIONS.117.005654.

  PMID: 30354636 DERIVED

• Ansel GM, Brodmann M, Keirse K, Micari A, Jaff MR, Rocha-Singh K, Fernandez EJ, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study. J Endovasc Ther. 2018 Dec;25(6):673-682. doi: 10.1177/1526602818803119. Epub 2018 Oct 3.

  PMID: 30280648 DERIVED

• Micari A, Brodmann M, Keirse K, Peeters P, Tepe G, Frost M, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study. JACC Cardiovasc Interv. 2018 May 28;11(10):945-953. doi: 10.1016/j.jcin.2018.02.019.

  PMID: 29798770 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Kristel Wittebols Clinical Research Director
• Organization: Medtronic

kristel.wittebols@medtronic.com

+31433566580

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: May 31, 2012
• Study Start: May 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: January 17, 2020
• Last Updated: March 25, 2021
• Results First Posted: January 28, 2019

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1); CZ (1); FR (2); CA (2); AR (2); HU (2); PT (1); RU (1); LI (1); BE (7); SL (1); GR (1); NL (5); AU (1); SG (1); CO (2); IL (2); KR (5); DE (9); SE (1); CH (3); PL (2); EG (2); IT (3); GB (2)