Clinical trial NCT01609296: IN.PACT Global Clinical Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease
Drug coated balloon
Superficial Femoral Artery
Popliteal Femoral Artery
Atherosclerosis
Drug eluting balloon
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2012-05-31
Enrollment: 1535
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Clinical Cohort ITT - Primary Effectiveness Endpoint
timeFrame: 12 months
measure: Clinical Cohort ITT - Primary Safety Endpoint
timeFrame: 12 months
measure: Imaging Cohort ITT - Primary Effectiveness Endpoint
timeFrame: 12 months
measure: 150mm DEB ITT Cohort - Primary Effectiveness Endpoint
timeFrame: 12 months
Secondary outcomes:
measure: Clinical Cohort ITT - MAEs
timeFrame: 12 months
measure: Clinical Cohort ITT - TLR
timeFrame: 12 months
measure: Clinical Cohort ITT - TVR
timeFrame: 12 months.
measure: Clinical Cohort ITT - Device Success
timeFrame: Index-procedure
measure: Clinical Cohort ITT - Clinical Success
timeFrame: prior to discharge
measure: Clinical Cohort ITT - MAEs
timeFrame: 60 months
measure: Clinical Cohort ITT - Clinically-driven TLR
timeFrame: 60 months
measure: Clinical Cohort ITT - TVR
timeFrame: 60 months
measure: Clinical Cohort ITT - TLR
timeFrame: 60 months
measure: Clinical Cohort ITT - Time to First Clinically-driven TLR (Days)
timeFrame: 60 months
measure: Clinical Cohort ITT - MAEs
timeFrame: 30 days
measure: Clinical Cohort ITT - MAEs
timeFrame: 6 Months
measure: Clinical Cohort ITT - MAEs
timeFrame: 24 Months
measure: Clinical Cohort ITT - MAEs
timeFrame: 36 Months
measure: Clinical Cohort ITT - MAEs
timeFrame: 48 Months
measure: Clinical Cohort ITT - Clinically-driven TLR
timeFrame: 30 days
measure: Clinical Cohort ITT - Clinically-driven TLR
timeFrame: 6 Months
measure: Clinical Cohort ITT - Clinically-driven TLR
timeFrame: 24 Months
measure: Clinical Cohort ITT - Clinically-driven TLR
timeFrame: 36 Months
measure: Clinical Cohort ITT - Clinically-driven TLR
timeFrame: 48 Months
measure: Clinical Cohort ITT - TLR
timeFrame: 6 Months
measure: Clinical Cohort ITT - TLR
timeFrame: 24 Months
measure: Clinical Cohort ITT - TLR
timeFrame: 36 Months
measure: Clinical Cohort ITT - TLR
timeFrame: 48 Months
measure: Clinical Cohort ITT - TVR
timeFrame: 24 Months
measure: Clinical Cohort ITT - TVR
timeFrame: 36 Months
measure: Clinical Cohort ITT - TVR
timeFrame: 48 Months
measure: Clinical Cohort ITT - TVR
timeFrame: 6 Months
measure: Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure.
timeFrame: 60 months
measure: Clinical Cohort ITT - Primary Sustained Clinical Improvement
timeFrame: 6 Months
measure: Clinical Cohort ITT - Primary Sustained Clinical Improvement
timeFrame: 12 Months
measure: Clinical Cohort ITT - Primary Sustained Clinical Improvement
timeFrame: 24 Months
measure: Clinical Cohort ITT - Primary Sustained Clinical Improvement
timeFrame: 36 Months
measure: Clinical Cohort ITT - Secondary Sustained Clinical Improvement
timeFrame: 6 Months
measure: Clinical Cohort ITT - Secondary Sustained Clinical Improvement
timeFrame: 12 Months
measure: Clinical Cohort ITT - Secondary Sustained Clinical Improvement
timeFrame: 24 Months
measure: Clinical Cohort ITT - Secondary Sustained Clinical Improvement
timeFrame: 36 Months
measure: Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure
timeFrame: Post procedure
measure: Clinical Cohort ITT - Sustained Hemodynamic Improvement
timeFrame: 6 Months
measure: Clinical Cohort ITT - Sustained Hemodynamic Improvement
timeFrame: 12 Months
measure: Clinical Cohort ITT - Sustained Hemodynamic Improvement
timeFrame: 24 Months
measure: Clinical Cohort ITT - Sustained Hemodynamic Improvement
timeFrame: 36 Months
measure: Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
timeFrame: 6 Months
measure: Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
timeFrame: 12 Months
measure: Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
timeFrame: 24 Months
measure: Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
timeFrame: 36 Months
measure: Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
timeFrame: 6 Months
measure: Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
timeFrame: 12 Months
measure: Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
timeFrame: 24 Months
measure: Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
timeFrame: 36 Months
measure: Clinical Cohort ITT - Procedural Success
timeFrame: at procedure
measure: Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion
timeFrame: at 12 months, or at the time of re-intervention
measure: Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion
timeFrame: At 12 months, or at the time of re-intervention
measure: 150mm DEB ITT Cohort - MAEs
timeFrame: 30 days
measure: 150mm DEB ITT Cohort - MAEs
timeFrame: 6 months
measure: 150mm DEB ITT Cohort - MAEs
timeFrame: 12 months
measure: 150mm DEB ITT Cohort - MAEs
timeFrame: 24 months
measure: 150mm DEB ITT Cohort - MAEs
timeFrame: 36 months
measure: 150mm DEB ITT Cohort - MAEs
timeFrame: 48 months
measure: 150mm DEB ITT Cohort - MAEs
timeFrame: 60 months
measure: 150mm DEB ITT Cohort - Clinically-driven TLR
timeFrame: 30 days
measure: 150mm DEB ITT Cohort - Clinically-driven TLR
timeFrame: 6 months
measure: 150mm DEB ITT Cohort - Clinically-driven TLR
timeFrame: 24 months
measure: 150mm DEB ITT Cohort - Clinically-driven TLR
timeFrame: 36 months
measure: 150mm DEB ITT Cohort - Clinically-driven TLR
timeFrame: 48 months
measure: 150mm DEB ITT Cohort - Clinically-driven TLR
timeFrame: 60 months
measure: 150mm DEB ITT Cohort - TLR
timeFrame: 6 Months
measure: 150mm DEB ITT Cohort - TLR
timeFrame: 12 Months
measure: 150mm DEB ITT Cohort - TLR
timeFrame: 24 Months
measure: 150mm DEB ITT Cohort - TLR
timeFrame: 36 Months
measure: 150mm DEB ITT Cohort - TLR
timeFrame: 48 Months
measure: 150mm DEB ITT Cohort - TLR
timeFrame: 60 Months
measure: 150mm DEB ITT Cohort - TVR
timeFrame: 6 Months
measure: 150mm DEB ITT Cohort - TVR
timeFrame: 12 Months
measure: 150mm DEB ITT Cohort - TVR
timeFrame: 24 Months
measure: 150mm DEB ITT Cohort - TVR
timeFrame: 36 Months
measure: 150mm DEB ITT Cohort - TVR
timeFrame: 48 Months
measure: 150mm DEB ITT Cohort - TVR
timeFrame: 60 Months
measure: 150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days)
timeFrame: 60 months
measure: 150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure.
timeFrame: 60 months
measure: 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
timeFrame: 6 months.
measure: 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
timeFrame: 12 months.
measure: 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
timeFrame: 24 months
measure: 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
timeFrame: 36 months
measure: 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
timeFrame: 6 Months
measure: 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
timeFrame: 12 Months
measure: 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
timeFrame: 24 Months
measure: 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
timeFrame: 36 Months
measure: 150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure
timeFrame: Post procedure
measure: 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
timeFrame: 6 Months
measure: 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
timeFrame: 12 Months
measure: 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
timeFrame: 24 Months
measure: 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
timeFrame: 36 Months
measure: 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
timeFrame: 6 Months
measure: 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
timeFrame: 12 Months
measure: 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
timeFrame: 24 Months
measure: 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
timeFrame: 36 Months
measure: 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
timeFrame: 6 Months
measure: 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
timeFrame: 12 Months
measure: 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
timeFrame: 24 Months
measure: 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
timeFrame: 36 Months
measure: 150mm DEB ITT Cohort - Device Success
timeFrame: Index-procedure
measure: 150mm DEB ITT Cohort - Procedural Success
timeFrame: at procedure
measure: 150mm DEB ITT Cohort - Clinical Success
timeFrame: prior to discharge
measure: Clinical Cohort ITT - All-cause Mortality
timeFrame: 30 days
measure: Clinical Cohort ITT - All-cause Mortality
timeFrame: 6 Months
measure: Clinical Cohort ITT - All-cause Mortality
timeFrame: 12 Months
measure: Clinical Cohort ITT - All-cause Mortality
timeFrame: 24 Months
measure: Clinical Cohort ITT - All-cause Mortality
timeFrame: 36 Months
measure: Clinical Cohort ITT - All-cause Mortality
timeFrame: 48 Months
measure: Clinical Cohort ITT - All-cause Mortality
timeFrame: 60 Months
measure: Clinical Cohort ITT - Clinically-driven TVR
timeFrame: 30 days
measure: Clinical Cohort ITT - Clinically-driven TVR
timeFrame: 6 Months
measure: Clinical Cohort ITT - Clinically-driven TVR
timeFrame: 12 Months
measure: Clinical Clinical Cohort ITT - Clinically-driven TVR
timeFrame: 24 Months
measure: Clinical Cohort ITT - Clinically-driven TVR
timeFrame: 36 Months
measure: Clinical Cohort ITT - Clinically-driven TVR
timeFrame: 48 Months
measure: Clinical Cohort ITT - Clinically-driven TVR
timeFrame: 60 Months
measure: Clinical Cohort ITT - Major Target Limb Amputation
timeFrame: 30 days
measure: Clinical Cohort ITT - Major Target Limb Amputation
timeFrame: 6 Months
measure: Clinical Cohort ITT - Major Target Limb Amputation
timeFrame: 12 Months
measure: Clinical Cohort ITT - Major Target Limb Amputation
timeFrame: 24 Months
measure: Clinical Cohort ITT - Major Target Limb Amputation
timeFrame: 36 Months
measure: Clinical Cohort ITT - Major Target Limb Amputation
timeFrame: 48 Months
measure: Clinical Cohort ITT - Major Target Limb Amputation
timeFrame: 60 Months
measure: 150mm DEB ITT Cohort - All-cause Mortality
timeFrame: 30 days
measure: 150mm DEB ITT Cohort - All-cause Mortality
timeFrame: 6 Months
measure: 150mm DEB ITT Cohort - All-cause Mortality
timeFrame: 12 Months
measure: 150mm DEB ITT Cohort - All-cause Mortality
timeFrame: 24 Months
measure: 150mm DEB ITT Cohort - All-cause Mortality
timeFrame: 36 Months
measure: 150mm DEB ITT Cohort - All-cause Mortality
timeFrame: 48 Months
measure: 150mm DEB ITT Cohort - All-cause Mortality
timeFrame: 60 Months
measure: 150mm DEB ITT Cohort - Clinically-driven TVR
timeFrame: 30 days
measure: 150mm DEB ITT Cohort - Clinically-driven TVR
timeFrame: 6 Months
measure: 150mm DEB ITT Cohort - Clinically-driven TVR
timeFrame: 12 Months
measure: 150mm DEB ITT Cohort - Clinically-driven TVR
timeFrame: 24 Months
measure: 150mm DEB ITT Cohort - Clinically-driven TVR
timeFrame: 36 Months
measure: 150mm DEB ITT Cohort - Clinically-driven TVR
timeFrame: 48 Months
measure: 150mm DEB ITT Cohort - Clinically-driven TVR
timeFrame: 60 Months
measure: 150mm DEB ITT Cohort - Major Target Limb Amputation
timeFrame: 30 days
measure: 150mm DEB ITT Cohort - Major Target Limb Amputation
timeFrame: 6 Months
measure: 150mm DEB ITT Cohort - Major Target Limb Amputation
timeFrame: 12 Months
measure: 150mm DEB ITT Cohort - Major Target Limb Amputation
timeFrame: 24 Months
measure: 150mm DEB ITT Cohort - Major Target Limb Amputation
timeFrame: 36 Months
measure: 150mm DEB ITT Cohort - Major Target Limb Amputation
timeFrame: 48 Months
measure: 150mm DEB ITT Cohort - Major Target Limb Amputation
timeFrame: 60 Months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Fundación Favaloro
city: Bueos Aires
country: Argentina
facility: Clinica La Sagrada Familia
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Mödling
country: Austria
facility: Landesklinikum Thermenregion Mödling
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenuis
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Dendermonde
country: Belgium
facility: AZ St. Blasius
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg - Campus St.-Jan
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Tienen
country: Belgium
facility: Regionaal Ziekenhuis Heilig Hart
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire Sherbrooke (CHUS)
city: Toronto
country: Canada
facility: Toronto General Hospital
city: Medellin
country: Colombia
facility: Clinica Santa Maria
city: Neiva
country: Colombia
facility: Clinica Medilaser Neiva
city: Hradec Kralove
country: Czechia
facility: Faculty Hospital Hradec Kralove
city: Cairo
country: Egypt
facility: As-Salam International Hospital
city: Cairo
country: Egypt
facility: Egypt Air Hospital
city: Helsinki
country: Finland
facility: Helsingin Seudun Yliopistollinen Keskussairaala
city: Bordeaux Cedex
country: France
facility: Group Hospitalier Pellegrin - CHU
city: Strasbourg
country: France
facility: Les Hospitaux Universitaires de Strasbourg
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Duesseldorf
country: Germany
facility: Augusta-Krankenhaus
city: Düsseldorf
country: Germany
facility: Augusta Krankenhaus
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig AoR
city: Leipzig
country: Germany
facility: Park-Krankenhaus Leipzig
city: Münster
country: Germany
facility: St. Franziskus Hospital GmbH
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Patra
country: Greece
facility: University Hospital of Patras
city: Budapest
country: Hungary
facility: Semmelweis University
city: Kecskemét
country: Hungary
facility: Bacs Kiskun Megyei Korhaz
city: Haifa
country: Israel
facility: Carmel Medical Centre
city: Petach Tikva
country: Israel
facility: Rabin Medical Center - Beilison Hospital
city: Catania
country: Italy
facility: Policlinico Vittorio Emanuele
city: Palermo
country: Italy
facility: Maria Eleonora Hospital
city: Rome
country: Italy
facility: Policlinico Gemelli
city: Seoul
country: Korea, Republic of
facility: Severence Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Kaunas
country: Lithuania
facility: Kaunas Mecial University Clinic
city: 's Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: Sint Antonius Hospital
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Katowice
country: Poland
facility: Euromedic Medical Center
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 2
city: Lisbon
country: Portugal
facility: Hospital Santa Marta
city: Moscow
country: Russian Federation
facility: City Clinical Hospital named after M.E. Zhadkevich
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Banská Bystrica
country: Slovakia
facility: Stredoslovensky ustav srdcovych a cievnych chorob (SUSCCH)
city: Bratislava
country: Slovakia
facility: Národný ústav srdcových a cievnych chorôb a.s. (NUSCH)
city: Kosice
country: Slovakia
facility: Východoslovenský ústav srdcových a cievnych chorôb, a.s.(VUSH)
city: Maribor
country: Slovenia
facility: University Medical Centre Maribor
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Bern
country: Switzerland
facility: Inselspital - Universitätsspial Bern
city: Fribourg
country: Switzerland
facility: Hopital Cantonal HFR
city: Luzern
country: Switzerland
facility: Kantonspital Luzern
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
Study officials:
affiliation: Klinikum Rosenheim
name: Gunnar Tepe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MidOhio Cardiology and Vascular Consultants
name: Gary Ansel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ Sint Blasius
name: Marc Bosiers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Swiss Cardiovascular Center, Inselspital
name: Do-Dai Do, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheffield Vascular Institute
name: Peter Gaines, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculdade de Ciências Médicas da Santa Casa de Sao Paulo
name: Alvaro Razuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.