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
Résumé de l'étude
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)
Intervention étudiée
Treatment of acute coronary syndrome with already approved and commonly used drug-eluting metallic stents.
(BASEC)
Maladie en cours d'investigation
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)
Critères d'exclusion
- under 18 years - Women who are pregnant or may become pregnant (BASEC)
Lieu de l’étude
Berne
(BASEC)
Sponsor
non disponible
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. Dr. Lorenz Räber
+41 31 632 2111
kardio.studien@clutterinsel.ch(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
20.07.2018
(BASEC)
Identifiant de l'essai ICTRP
NCT03440801 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
non disponible
Titre académique
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)
Titre public
A Randomized Comparison of Long-Term Healing Between Biodegradable- Versus Durable-Polymer Everolimus Eluting Stents in STEMI (ICTRP)
Maladie en cours d'investigation
STEMI - ST Elevation Myocardial Infarction
(ICTRP)
Intervention étudiée
Device: Synergy
Device: Xience
(ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
Frequency of neoatheroslcerosis
(ICTRP)
Athero-thrombotic material area
(ICTRP)
Date d'enregistrement
12.02.2018 (ICTRP)
Inclusion du premier participant
03.07.2017 (ICTRP)
Sponsors secondaires
University Hospital Inselspital, Berne
(ICTRP)
Contacts supplémentaires
Masanori Taniwaki, MD, grand_wagoneer_797@hotmail.com, +81 429408611 (ICTRP)
ID secondaires
CONNECT1 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
http://www.who.int/trialsearch/Trial2.aspx?TrialID=NCT03440801 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible