SwePub
Sök i LIBRIS databas

  Utökad sökning

onr:"swepub:oai:DiVA.org:uu-342776"
 

Sökning: onr:"swepub:oai:DiVA.org:uu-342776" > Report of an ESC-EA...

Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention : executive summary

Byrne, Robert A (författare)
Stefanini, Giulio G (författare)
Capodanno, Davide (författare)
Univ Catania, Ferrarotto Hosp, Cardiothorac Vasc Dept, Catania, Italy.
visa fler...
Onuma, Yoshinobu (författare)
Erasmus MC, Dept Intervent Cardiol, Rotterdam, Netherlands.
Baumbach, Andreas (författare)
St Bartholomews Hosp, William Harvey Res Inst, Dept Cardiol, London, England.;Queen Mary Univ London, London, England.
Escaned, Javier (författare)
Hosp San Carlos, Intervent Cardiol, Madrid, Spain.
Haude, Michael (författare)
Lukaskrankenhaus GmbH, Stadtisches Kliniken Neuss, Med Clin 1, Neuss, Germany.
James, Stefan K, 1964- (författare)
Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Institutionen för medicinska vetenskaper
Joner, Michael (författare)
Tech Univ Munich, Deutsch Herzzentrum Munchen, Munich, Germany.;DZHK German Ctr Cardiovasc Res, Partner Site Munich Heart Alliance, Munich, Germany.
Jüni, Peter (författare)
Univ Toronto, St Michaels Hosp, Li Ka Shing Knowledge Inst, Appl Hlth Res Ctr, Toronto, ON, Canada.
Kastrati, Adnan (författare)
Tech Univ Munich, Deutsch Herzzentrum Munchen, Munich, Germany.;DZHK German Ctr Cardiovasc Res, Partner Site Munich Heart Alliance, Munich, Germany.
Oktay, Semih (författare)
Cardio Med Device Consultants, Baltimore, MD USA.
Wijns, William (författare)
Saolta Univ, Healthcare Grp, Galway, Ireland.;Natl Univ Ireland, Lambe Inst Translat Med & Curam, Galway, Ireland.
Serruys, Patrick W (författare)
Windecker, Stephan (författare)
Bern Univ Hosp, Cardiovasc Ctr Bern, Bern, Switzerland.
Serruys, Patrick W. (författare)
Erasmus Univ, Rotterdam, Netherlands.;Imperial Coll London, Natl Heart & Lung Inst, Int Ctr Circulatory Hlth, London, England.
Byrne, Robert A. (författare)
Tech Univ Munich, Deutsch Herzzentrum Munchen, Munich, Germany.;DZHK German Ctr Cardiovasc Res, Partner Site Munich Heart Alliance, Munich, Germany.
Stefanini, Giulio G. (författare)
Humanitas Res Hosp, Cardio Ctr, Div Cardiol, Milan, Italy.
visa färre...
Univ Catania, Ferrarotto Hosp, Cardiothorac Vasc Dept, Catania, Italy Erasmus MC, Dept Intervent Cardiol, Rotterdam, Netherlands. (creator_code:org_t)
EUROPA EDITION, 2018
2018
Engelska.
Ingår i: European Heart Journal. - : EUROPA EDITION. - 0195-668X .- 1522-9645. ; 13:13, s. 1574-1586
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the non-clinical and clinical evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device-the Absorb bioresorbable vascular scaffold-has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice. The Task Force recommends that new BRS devices should undergo systematic non-clinical testing according to standardized criteria prior to evaluation in clinical studies. A clinical evaluation plan should include data from a medium sized, randomized trial against DES powered for a surrogate end point of clinical efficacy. Manufacturers of successful devices receive CE-mark approval for use and must have an approved plan for a large-scale randomized clinical trial with planned long-term follow-up.

Ämnesord

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kardiologi (hsv//swe)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine (hsv//eng)

Nyckelord

Bioresorbable scaffold
Clinical trials
Expert review
Regulatory approval
bioresorbable scaffold
clinical trials
expert review
regulatory approval

Publikations- och innehållstyp

ref (ämneskategori)
art (ämneskategori)

Hitta via bibliotek

Till lärosätets databas

 
pil uppåt Stäng

Kopiera och spara länken för att återkomma till aktuell vy