IN.PACT Global Clinical Study

NCT ID: NCT01609296

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1535 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2020-01-17

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.

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

IN.PACT Admiral™ Drug Eluting Balloon

Intervention Type: DEVICE

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

Interventions

IN.PACT Admiral™ Drug Eluting Balloon

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

Intervention Type: DEVICE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Endovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gunnar Tepe, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Rosenheim

Gary Ansel, MD

Role: PRINCIPAL_INVESTIGATOR

MidOhio Cardiology and Vascular Consultants

Marc Bosiers, MD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint Blasius

Do-Dai Do, MD

Role: PRINCIPAL_INVESTIGATOR

Swiss Cardiovascular Center, Inselspital

Peter Gaines, MD

Role: PRINCIPAL_INVESTIGATOR

Sheffield Vascular Institute

Alvaro Razuk, MD

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Ciências Médicas da Santa Casa de Sao Paulo

Locations

Fundación Favaloro

Buenos Aires, , Argentina

Clinica La Sagrada Familia

Bueos Aires, , Argentina

Royal Prince Alfred Hospital

Sydney, , Australia

Medizinische Universität Graz

Graz, , Austria

Landesklinikum Thermenregion Mödling

Mödling, , Austria

Onze-Lieve-Vrouwziekenuis

Aalst, , Belgium

Imelda Ziekenhuis

Bonheiden, , Belgium

AZ St. Blasius

Dendermonde, , Belgium

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Ziekenhuis Oost Limburg - Campus St.-Jan

Genk, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

Regionaal Ziekenhuis Heilig Hart

Tienen, , Belgium

Centre hospitalier universitaire Sherbrooke (CHUS)

Sherbrooke, , Canada

Toronto General Hospital

Toronto, , Canada

Clinica Santa Maria

Medellín, , Colombia

Clinica Medilaser Neiva

Neiva, , Colombia

Faculty Hospital Hradec Kralove

Hradec Králové, , Czechia

As-Salam International Hospital

Cairo, , Egypt

Egypt Air Hospital

Cairo, , Egypt

Helsingin Seudun Yliopistollinen Keskussairaala

Helsinki, , Finland

Group Hospitalier Pellegrin - CHU

Bordeaux, , France

Les Hospitaux Universitaires de Strasbourg

Strasbourg, , France

Herzzentrum Bad Krozingen

Bad Krozingen, , Germany

Augusta Krankenhaus

Düsseldorf, , Germany

Augusta-Krankenhaus

Düsseldorf, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Universitatsklinikum Leipzig AoR

Leipzig, , Germany

Park-Krankenhaus Leipzig

Leipzig, , Germany

St. Franziskus Hospital GmbH

Münster, , Germany

RoMed Klinikum Rosenheim

Rosenheim, , Germany

Universitätsklinikum Tübingen

Tübingen, , Germany

University Hospital of Patras

Pátrai, , Greece

Semmelweis University

Budapest, , Hungary

Bacs Kiskun Megyei Korhaz

Kecskemét, , Hungary

Carmel Medical Centre

Haifa, , Israel

Rabin Medical Center - Beilison Hospital

Petah Tikva, , Israel

Policlinico Vittorio Emanuele

Catania, , Italy

Maria Eleonora Hospital

Palermo, , Italy

Policlinico Gemelli

Rome, , Italy

Kaunas Mecial University Clinic

Kaunas, , Lithuania

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Rijnstate Ziekenhuis

Arnhem, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

Sint Antonius Hospital

Nieuwegein, , Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, , Netherlands

Euromedic Medical Center

Katowice, , Poland

Samodzielny Publiczny Szpital Kliniczny Nr 2

Szczecin, , Poland

Hospital Santa Marta

Lisbon, , Portugal

City Clinical Hospital named after M.E. Zhadkevich

Moscow, , Russia

Changi General Hospital

Singapore, , Singapore

Stredoslovensky ustav srdcovych a cievnych chorob (SUSCCH)

Banská Bystrica, , Slovakia

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

Bratislava, , Slovakia

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

Košice, , Slovakia

University Medical Centre Maribor

Maribor, , Slovenia

Severence Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Ajou University Hospital

Suwon, , South Korea

Karolinska Universitetssjukhuset

Solna, , Sweden

Inselspital - Universitätsspial Bern

Bern, , Switzerland

Hopital Cantonal HFR

Fribourg, , Switzerland

Kantonspital Luzern

Lucerne, , Switzerland

Manchester Royal Infirmary

Manchester, , United Kingdom

Northern General Hospital

Sheffield, , United Kingdom

Countries

Argentina; Australia; Austria; Belgium; Canada; Colombia; Czechia; Egypt; Finland; France; Germany; Greece; Hungary; Israel; Italy; Lithuania; Netherlands; Poland; Portugal; Russia; Singapore; Slovakia; Slovenia; South Korea; Sweden; Switzerland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 38348677 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36137674 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35864209 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35635160 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32583749 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31543165 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30931726 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30846089 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30690141 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30630355 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30354645 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30354636 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30280648 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29798770 (View on PubMed)

Other Identifiers

10048613

Identifier Type: -

Identifier Source: org_study_id