Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease-The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study.
Identifieur interne : 000337 ( PubMed/Corpus ); précédent : 000336; suivant : 000338Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease-The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study.
Auteurs : Herman Schroë ; Andrew H. Holden ; Yann Goueffic ; Shirley J. Jansen ; Patrick Peeters ; Koen Keirse ; Wulf Ito ; Frank Vermassen ; Antonio Micari ; Erwin Blessing ; Michael R. Jaff ; Thomas ZellerSource :
- Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions [ 1522-726X ] ; 2017.
Abstract
The purpose of this study was to assess the safety and performance of Stellarex Drug-coated balloon (DCB).
DOI: 10.1002/ccd.27348
PubMed: 29086462
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease-The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study.</title><author><name sortKey="Schroe, Herman" sort="Schroe, Herman" uniqKey="Schroe H" first="Herman" last="Schroë">Herman Schroë</name><affiliation><nlm:affiliation>Ziekenhuis Oost-Limburg, Genk, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Holden, Andrew H" sort="Holden, Andrew H" uniqKey="Holden A" first="Andrew H" last="Holden">Andrew H. Holden</name><affiliation><nlm:affiliation>Department of Interventional Radiology, Auckland City Hospital, Auckland, New Zealand.</nlm:affiliation></affiliation></author><author><name sortKey="Goueffic, Yann" sort="Goueffic, Yann" uniqKey="Goueffic Y" first="Yann" last="Goueffic">Yann Goueffic</name><affiliation><nlm:affiliation>CHU de Nantes, Nantes, France.</nlm:affiliation></affiliation></author><author><name sortKey="Jansen, Shirley J" sort="Jansen, Shirley J" uniqKey="Jansen S" first="Shirley J" last="Jansen">Shirley J. Jansen</name><affiliation><nlm:affiliation>Vascular and Endovascular Surgery, Sir Charles Gairdner Hospital, Health and Medical Sciences, University of Western Australia, School of Population Health, Curtin University, Perth, Western Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Peeters, Patrick" sort="Peeters, Patrick" uniqKey="Peeters P" first="Patrick" last="Peeters">Patrick Peeters</name><affiliation><nlm:affiliation>Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Keirse, Koen" sort="Keirse, Koen" uniqKey="Keirse K" first="Koen" last="Keirse">Koen Keirse</name><affiliation><nlm:affiliation>Department of Vascular Surgery, Heilig Hart Hospital, Tienen, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Ito, Wulf" sort="Ito, Wulf" uniqKey="Ito W" first="Wulf" last="Ito">Wulf Ito</name><affiliation><nlm:affiliation>Medical Department II, Experimental Angiology, University Hospital Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Vermassen, Frank" sort="Vermassen, Frank" uniqKey="Vermassen F" first="Frank" last="Vermassen">Frank Vermassen</name><affiliation><nlm:affiliation>Department of Vascular Surgery, Universitair Ziekenhuis Gent, Ghent, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Micari, Antonio" sort="Micari, Antonio" uniqKey="Micari A" first="Antonio" last="Micari">Antonio Micari</name><affiliation><nlm:affiliation>GVM Care & Research Interventional Cardiology Unit, Maria Cecilia Hospital, Cotignola, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Blessing, Erwin" sort="Blessing, Erwin" uniqKey="Blessing E" first="Erwin" last="Blessing">Erwin Blessing</name><affiliation><nlm:affiliation>SRH Klinikum Karlsbad Langensteinbach, Karlsbad, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Jaff, Michael R" sort="Jaff, Michael R" uniqKey="Jaff M" first="Michael R" last="Jaff">Michael R. Jaff</name><affiliation><nlm:affiliation>VasCore, Massachusetts General Hospital, Boston, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Zeller, Thomas" sort="Zeller, Thomas" uniqKey="Zeller T" first="Thomas" last="Zeller">Thomas Zeller</name><affiliation><nlm:affiliation>Angiology Division, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:29086462</idno><idno type="pmid">29086462</idno><idno type="doi">10.1002/ccd.27348</idno><idno type="wicri:Area/PubMed/Corpus">000337</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000337</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease-The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study.</title><author><name sortKey="Schroe, Herman" sort="Schroe, Herman" uniqKey="Schroe H" first="Herman" last="Schroë">Herman Schroë</name><affiliation><nlm:affiliation>Ziekenhuis Oost-Limburg, Genk, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Holden, Andrew H" sort="Holden, Andrew H" uniqKey="Holden A" first="Andrew H" last="Holden">Andrew H. Holden</name><affiliation><nlm:affiliation>Department of Interventional Radiology, Auckland City Hospital, Auckland, New Zealand.</nlm:affiliation></affiliation></author><author><name sortKey="Goueffic, Yann" sort="Goueffic, Yann" uniqKey="Goueffic Y" first="Yann" last="Goueffic">Yann Goueffic</name><affiliation><nlm:affiliation>CHU de Nantes, Nantes, France.</nlm:affiliation></affiliation></author><author><name sortKey="Jansen, Shirley J" sort="Jansen, Shirley J" uniqKey="Jansen S" first="Shirley J" last="Jansen">Shirley J. Jansen</name><affiliation><nlm:affiliation>Vascular and Endovascular Surgery, Sir Charles Gairdner Hospital, Health and Medical Sciences, University of Western Australia, School of Population Health, Curtin University, Perth, Western Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Peeters, Patrick" sort="Peeters, Patrick" uniqKey="Peeters P" first="Patrick" last="Peeters">Patrick Peeters</name><affiliation><nlm:affiliation>Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Keirse, Koen" sort="Keirse, Koen" uniqKey="Keirse K" first="Koen" last="Keirse">Koen Keirse</name><affiliation><nlm:affiliation>Department of Vascular Surgery, Heilig Hart Hospital, Tienen, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Ito, Wulf" sort="Ito, Wulf" uniqKey="Ito W" first="Wulf" last="Ito">Wulf Ito</name><affiliation><nlm:affiliation>Medical Department II, Experimental Angiology, University Hospital Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Vermassen, Frank" sort="Vermassen, Frank" uniqKey="Vermassen F" first="Frank" last="Vermassen">Frank Vermassen</name><affiliation><nlm:affiliation>Department of Vascular Surgery, Universitair Ziekenhuis Gent, Ghent, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Micari, Antonio" sort="Micari, Antonio" uniqKey="Micari A" first="Antonio" last="Micari">Antonio Micari</name><affiliation><nlm:affiliation>GVM Care & Research Interventional Cardiology Unit, Maria Cecilia Hospital, Cotignola, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Blessing, Erwin" sort="Blessing, Erwin" uniqKey="Blessing E" first="Erwin" last="Blessing">Erwin Blessing</name><affiliation><nlm:affiliation>SRH Klinikum Karlsbad Langensteinbach, Karlsbad, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Jaff, Michael R" sort="Jaff, Michael R" uniqKey="Jaff M" first="Michael R" last="Jaff">Michael R. Jaff</name><affiliation><nlm:affiliation>VasCore, Massachusetts General Hospital, Boston, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Zeller, Thomas" sort="Zeller, Thomas" uniqKey="Zeller T" first="Thomas" last="Zeller">Thomas Zeller</name><affiliation><nlm:affiliation>Angiology Division, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions</title><idno type="eISSN">1522-726X</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The purpose of this study was to assess the safety and performance of Stellarex Drug-coated balloon (DCB).</div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">29086462</PMID><DateCreated><Year>2017</Year><Month>10</Month><Day>31</Day></DateCreated><DateRevised><Year>2017</Year><Month>10</Month><Day>31</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1522-726X</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2017</Year><Month>Oct</Month><Day>31</Day></PubDate></JournalIssue><Title>Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions</Title><ISOAbbreviation>Catheter Cardiovasc Interv</ISOAbbreviation></Journal><ArticleTitle>Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease-The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study.</ArticleTitle><ELocationID EIdType="doi" ValidYN="Y">10.1002/ccd.27348</ELocationID><Abstract><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">The purpose of this study was to assess the safety and performance of Stellarex Drug-coated balloon (DCB).</AbstractText><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">DCB coatings differ in excipients, paclitaxel dose, and coating morphologies. Due to these differences, a class effect with DCBs has not been demonstrated. Consequently, each DCB needs to be evaluated independently based on its own clinical study results.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">The ILLUMENATE Global Study is a prospective, multicenter, single-arm study. Patients with intermittent claudication or ischemic rest pain due to superficial femoral artery (SFA) and/or popliteal peripheral artery disease (PAD) were treated with the Stellarex DCB. The primary efficacy endpoint was primary patency, defined as freedom from restenosis with peak systolic velocity ratio ≤2.5 or clinically-driven target lesion revascularization (CD-TLR) at 12 months. The primary safety endpoint was freedom from device and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and CD-TLR through 12 months.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">In total, 417 lesions were treated in 371 patients. The mean lesion length was 7.5 ± 5.3 cm, 40.8% of lesions were severely calcified per core laboratory fluoroscopy criteria and 31.3% were total occlusions. Primary patency by independent duplex core lab evaluation was 81.4% and the freedom from CD-TLR was 94.8% day 365 per Kaplan-Meier estimate. The majority of patients experienced improvements in their Rutherford classification (90.3%) and walking impairment questionnaire score (83.6%) at 12 months compared to baseline.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">This study validated previous positive findings and confirms the strong safety profile and effectiveness outcomes.</AbstractText><CopyrightInformation>© 2017 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Schroë</LastName><ForeName>Herman</ForeName><Initials>H</Initials><Identifier Source="ORCID">http://orcid.org/0000-0003-4568-2458</Identifier><AffiliationInfo><Affiliation>Ziekenhuis Oost-Limburg, Genk, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Holden</LastName><ForeName>Andrew H</ForeName><Initials>AH</Initials><AffiliationInfo><Affiliation>Department of Interventional Radiology, Auckland City Hospital, Auckland, New Zealand.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Goueffic</LastName><ForeName>Yann</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>CHU de Nantes, Nantes, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jansen</LastName><ForeName>Shirley J</ForeName><Initials>SJ</Initials><AffiliationInfo><Affiliation>Vascular and Endovascular Surgery, Sir Charles Gairdner Hospital, Health and Medical Sciences, University of Western Australia, School of Population Health, Curtin University, Perth, Western Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Peeters</LastName><ForeName>Patrick</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Keirse</LastName><ForeName>Koen</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Department of Vascular Surgery, Heilig Hart Hospital, Tienen, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ito</LastName><ForeName>Wulf</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Medical Department II, Experimental Angiology, University Hospital Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Cardiology, University Hospital Hamburg Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Max-Planck Institute of Heart and Lung Research, Ludwigstraße 43, 61231, Bad Nauheim, Germany.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Cardiovascular Center Oberallgaeu-Kempten, Academic Teaching Hospital, University of Ulm, Im Stillen 2, Immenstadt, 87509, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vermassen</LastName><ForeName>Frank</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Department of Vascular Surgery, Universitair Ziekenhuis Gent, Ghent, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Micari</LastName><ForeName>Antonio</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>GVM Care & Research Interventional Cardiology Unit, Maria Cecilia Hospital, Cotignola, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Blessing</LastName><ForeName>Erwin</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>SRH Klinikum Karlsbad Langensteinbach, Karlsbad, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jaff</LastName><ForeName>Michael R</ForeName><Initials>MR</Initials><AffiliationInfo><Affiliation>VasCore, Massachusetts General Hospital, Boston, MA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zeller</LastName><ForeName>Thomas</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Angiology Division, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>10</Month><Day>31</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Catheter Cardiovasc Interv</MedlineTA><NlmUniqueID>100884139</NlmUniqueID><ISSNLinking>1522-1946</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">drug-coated balloon</Keyword><Keyword MajorTopicYN="N">peripheral arterial disease</Keyword><Keyword MajorTopicYN="N">superficial femoral artery</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2017</Year><Month>08</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2017</Year><Month>08</Month><Day>30</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2017</Year><Month>08</Month><Day>31</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>11</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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