Randomized, multicenter comparative study of an everolimus-coated coronary stent with biodegradable polymer compared to an everolimus-coated coronary stent with durable polymer in patients with acute myocardial infarction. A serial imaging study using intracoronary optical coherence tomography - CONNECT study
Descrizione riassuntiva dello studio
In this study, we compare two different drug-eluting metallic stents that are already approved and used in everyday practice for the treatment of acute coronary syndrome in patients with acute ST-elevation myocardial infarction. In approximately one-third of the stents, there is a long-term reformation of cholesterol deposits in the newly formed vessel intima (reformation of vascular wall changes). We want to verify whether this occurs less frequently with stents that have biodegradable polymer (= carrier substance that holds the drug on the metal; Synergy stent) than with stents that have durable polymer (Xience stent). For this purpose, two imaging sessions will be performed; one right at the beginning after implantation and a second imaging session after 3 years, each using special images from the inside of the heart vessel.
(BASEC)
Intervento studiato
Treatment of acute coronary syndrome with already approved and commonly used drug-eluting metallic stents.
(BASEC)
Malattie studiate
Stent implantation in acute myocardial infarction (ST-elevation myocardial infarction)
(BASEC)
- acute ST-elevation myocardial infarction - treatment within the first 24 hours after symptom onset via a coronary catheter examination with stent implantation (primary percutaneous coronary intervention) (BASEC)
Criteri di esclusione
- under 18 years - Women who are pregnant or may become pregnant (BASEC)
Luogo dello studio
Berna
(BASEC)
Sponsor
non disponibile
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. Dr. Lorenz Räber
+41 31 632 2111
kardio.studien@clutterinsel.ch(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
20.07.2018
(BASEC)
ID di studio ICTRP
NCT03440801 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
non disponibile
Titolo accademico
A Randomized COmparison of LoNg-Term Vascular HealiNg bEtween Biodegradable -Polymer (BP) Versus Durable Polymer (DP) Everolimus Eluting Stents in Acute ST-Elevation Myocardial InfarCTion (ICTRP)
Titolo pubblico
A Randomized Comparison of Long-Term Healing Between Biodegradable- Versus Durable-Polymer Everolimus Eluting Stents in STEMI (ICTRP)
Malattie studiate
STEMI - ST Elevation Myocardial Infarction
(ICTRP)
Intervento studiato
Device: Synergy
Device: Xience
(ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria: 1. Age =18 years 2. Primary PCI within 24 hours of symptom onset 3. ST-segment elevation of > 1mm in > 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >1mm in >2 contiguuoius anterior leads 4. Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.5 mm in diameter that can be covered with one or multiple stents Exclusion Criteria: 1. Female ofchildbearing potential (age < 50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy. 2. Known intolerance to aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, cobalt chromium, platinum chromium, everolimus or contrast material 3. Inability to understand and provide informed consent 4. Currently participating in another trial before reaching first endpoint 5. Mechanical complications of acute myocardial infarction 6. Acute myocardial infarction secondary to stent thrombosis or restenosis 7. Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period 8. Noncardiac comorbid conditions are present with life expectancy 90 years 12. LV-function at index procedure
Minimum age: 20 Years
Maximum age: 90 Years
Sex: All (ICTRP)
non disponibile
Endpoint primari e secondari
Frequency of neoatheroslcerosis
(ICTRP)
Athero-thrombotic material area
(ICTRP)
Data di registrazione
12.02.2018 (ICTRP)
Inclusione del primo partecipante
03.07.2017 (ICTRP)
Sponsor secondari
University Hospital Inselspital, Berne
(ICTRP)
Contatti aggiuntivi
Masanori Taniwaki, MD, grand_wagoneer_797@hotmail.com, +81 429408611 (ICTRP)
ID secondari
CONNECT1 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
http://www.who.int/trialsearch/Trial2.aspx?TrialID=NCT03440801 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile