BIOTRONIK - une étude prospective multicentrique à un seul bras pour évaluer la sécurité et l'efficacité du système de stent coronaire à élution SiroLimus de 48 mm Orsiro Mission pour le traitement des sujets présentant des lésions athéroscléreuses (BIOFLOW-48)
The purpose of the study is to assess the safety and efficacy of the Orsiro® Mission 48- mm Sirolimus-Eluting Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) >36 mm and ≤ 44 mm in length (by visual estimate) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm.
Patients enrolled in the United States will be followed for 2 years post index procedure with follow-up visits at 1, 6, 12 months and 2 years post index procedure. Patients enrolled outside of the United States will be followed through 5 years post index procedure with additional follow-up visits at 3 and 5 years post index procedure.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: BIOFLOW-48 Project Manager
- Numéro de téléphone: 1-866-246-6990
- E-mail: bioflow-48@teleflex.com
Lieux d'étude
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Baden-Wurttemberg
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Mannheim, Baden-Wurttemberg, Allemagne, 68167
- Actif, ne recrute pas
- Universitätsklinikum Mannheim, I. Medizinische Klinik
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Bavaria
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Fürth, Bavaria, Allemagne, 90766
- Actif, ne recrute pas
- Klinikum Fürth
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Würzburg, Bavaria, Allemagne, 97080
- Retiré
- Universitätsklinikum Würzburg
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Schleswig-Holstein
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Bad Segeberg, Schleswig-Holstein, Allemagne, 23795
- Actif, ne recrute pas
- Segeberger Kliniken GmbH
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Auvergne-Rhône-Alpes
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Lyon, Auvergne-Rhône-Alpes, France, 69002
- Actif, ne recrute pas
- Hospices Civils de Lyon - CHU de Lyon
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Grand Est
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Essey-lès-Nancy, Grand Est, France, 54270
- Actif, ne recrute pas
- Clinique Louis Pasteur
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Provence-Alpes-Côte d'Azur Region
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Saint-Laurent-du-Var, Provence-Alpes-Côte d'Azur Region, France, 06700
- Actif, ne recrute pas
- Institut Arnault Tzanck
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Île-de-France Region
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Paris, Île-de-France Region, France, 75014
- Actif, ne recrute pas
- Hôpital Cochin - Groupe AP-HP
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State of Vienna
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Vienna, State of Vienna, L'Autriche, 1090
- Actif, ne recrute pas
- Universitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie, Medizinische Universität Wien
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Styria
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Graz, Styria, L'Autriche, 8036
- Actif, ne recrute pas
- Klinische Abteilung für Kardiologie, Medizinische Universität Graz
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Lower Silesian Voivodeship
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Lubin, Lower Silesian Voivodeship, Pologne, 59-301
- Actif, ne recrute pas
- Miedziowe Centrum Zdrowia SA
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Canton Ticino
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Lugano, Canton Ticino, Suisse, 6900
- Actif, ne recrute pas
- Istituto Cardiocentro Ticino
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Canton of Basel-City
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Basel, Canton of Basel-City, Suisse, 4031
- Actif, ne recrute pas
- University hospital Basel
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California
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Concord, California, États-Unis, 94520
- Recrutement
- John Muir Medical Center
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Kansas
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Wichita, Kansas, États-Unis, 67214
- Recrutement
- Ascension Via Christi Hospitals Wichita
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Recrutement
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, États-Unis, 48202
- Recrutement
- Henry Ford Hospital
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Missouri
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St Louis, Missouri, États-Unis, 63110
- Recrutement
- Barnes Jewish Hospital
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New York
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Manhasset, New York, États-Unis, 11030
- Recrutement
- North Shore University Hospital
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New York, New York, États-Unis, 10032
- Recrutement
- Columbia University Irving Medical Center/New York Presbyterian Hospital
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Texas
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Dallas, Texas, États-Unis, 75226
- Recrutement
- Baylor Scott & White The Heart Hospital - Dallas
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Kyle, Texas, États-Unis, 78640
- Recrutement
- Ascension Texas Cardiovascular
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West Virginia
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Charleston, West Virginia, États-Unis, 25304
- Recrutement
- Charleston Area Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
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Subject is ≥ 18 years of age
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Subject is able to understand the nature of the study and provide written informed consent.
For sites outside of the United States: Note: For subjects presenting with STEMI and not in a position to read, interpret and sign the informed consent form, oral informed consent is required.
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Subject is an acceptable candidate for percutaneous coronary intervention (PCI) according to the applicable guidelines.
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Subject is an acceptable candidate for CABG.
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Subject is eligible for dual antiplatelet therapy (DAPT) according to guidelines.
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Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia.
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Subject is willing and able to comply with study follow-up requirements.
Angiographic inclusion criteria:
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Subject has only one target lesion in a native coronary artery to be treated with the investigational device.
Note: One additional non-target lesion may be treated with a non-investigational treatment (e.g. stent, balloon angioplasty, atherectomy) with the exception of brachytherapy, if it is located in a different coronary artery. The non-target lesion must be treated first and must be deemed an angiographic success. (Angiographic success is defined by a residual diameter stenosis < 30% with TIMI 3 flow, as visually assessed by the physician, without the presence of prolonged chest pain or ECG changes consistent with MI.)
Note: Multiple focal stenoses will be considered as a single lesion if they are amenable to treatment with a single study device.
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Target lesion must be > 36 mm and ≤ 44 mm in length by operator visual estimate and must be amenable to treatment with a single study device.
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Target vessel must have a reference vessel diameter of 2.25-4.0 mm by operator visual estimate.
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For sites in United States: Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only.
For sites outside of the United States: Target lesion can be de novo, restenotic or in-stent restenotic, and must be located in a native coronary artery.
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Target lesion must have angiographic evidence of ≥ 50% and < 100% stenosis (by operator visual estimate which may be assisted by QCA / IVUS / OCT). Target lesion stenosis < 70% should have clinical justification for treatment as per local standards.
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Target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow > 1.
For sites outside of the United States: Note: For STEMI, TIMI flow > 1 prior to stent implantation (after opening the vessel with a guide wire or a balloon).
Exclusion Criteria:
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For sites in United States only: Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure.
Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment.
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Subject is hemodynamically unstable.
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Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
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Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), acrylic, fluoropolymers, silicon carbide, PLLA or sirolimus.
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Revascularization of any target vessel within 12 months prior to the index procedure or previous PCI of any non-target vessel within <72 hours prior to the index procedure.
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Future planned PCI (including staged procedure) or CABG after the index procedure.
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Planned surgery or dental surgical procedure within 6 months of index procedure unless dual antiplatelet therapy can be maintained throughout the peri-surgical period.
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History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure.
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Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for DAPT.
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Subject will refuse blood transfusions.
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Subject has a left ventricular ejection fraction (LVEF) < 30% within 6 months prior to or during the index procedure that was documented by any method.
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Subject is dialysis dependent or has impaired renal function (i.e., serum creatinine > 2.5 mg/dL or 221 µmol/L, determined within 7 days prior to the index procedure).
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Subject has a documented white blood cell count < 3,000 white blood cells/mm3 or a documented platelet count < 100,000 platelets/mm3 or > 700,000 platelets/mm3.
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Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted).
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Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure or has a malignancy that is not in remission.
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Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e. triple therapy) can be maintained according to guidelines.
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Subject has life expectancy of < 1 year.
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Subject is currently participating or plans to participate in another clinical investigation with an investigational device or an investigational drug.
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In the investigator's opinion, subject will not be able to comply with the follow-up requirements.
Angiographic exclusion criteria:
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Target lesion is excluded if it meets any of the following criteria:
- Lesion is located within or treated through a saphenous vein graft or arterial graft.
- Lesion location is within the left main coronary artery.
- Lesion location is within 3 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX) coronary arteries.
- Involves a side branch of > 2.0 mm in diameter that requires a two-device strategy after pre-dilatation.
- Lesion is totally occluded (100% stenosis).
- For sites in United States only: Lesion is a restenotic lesion that was previously treated with a bare metal or drug eluting stent (in-stent restenosis).
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Target vessel/lesion is excessively tortuous/angulated or is severely calcified, that would prevent complete inflation of an angioplasty balloon. This assessment should be based on visual estimation.
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Site sites in the United States: Target vessel has angiographic evidence of thrombus.
For sites outside of the United States: Target vessel has angiographic evidence of unresolved large thrombus burden despite of thrombus aspiration.
Note: Thrombus aspiration is left at the discretion of the implanting physician.
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Target vessel was treated with brachytherapy any time prior to the index procedure.
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Unsuccessful target lesion pre-dilatation, defined as residual stenosis > 50% (by visual estimation) and/or angiographic complications (e.g., distal embolization, side branch closure, dissection greater than National Heart, Lung, Blood Institute type C), and/or, for sites outside of the United States, coronary aneurysms.
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Non-target lesion is excluded if it meets any of the following criteria:
- Any of the target lesion angiographic exclusion criteria except for 1c
- Lesion is located within the target vessel.
- Lesion is > 36 mm by operator visual estimate.
- Lesion requires additional, unplanned stents to treat a complication.
- Lesion treatment is not deemed an angiographic success. (Angiographic success is defined by a residual diameter stenosis < 30% with TIMI 3 flow, as visually assessed by the physician, without the presence of prolonged chest pain or ECG changes consistent with MI.)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Système de stent coronaire à élution de sirolimus Orsiro Mission de 48 mm
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Orsiro Mission is composed of a device (coronary stent system including a cobalt chromium stent platform) and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Target Lesion Failure (TLF) rate at 12 months post-index procedure
Délai: 12 months
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The primary endpoint will be target lesion failure (TLF) rate at 12 months post-index procedure. TLF is defined as a composite of cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR). |
12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Décès toutes causes confondues
Délai: Procédure post-index à 1, 6, 12 mois et 2, 3 et 5 ans
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Procédure post-index à 1, 6, 12 mois et 2, 3 et 5 ans
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Tout infarctus du myocarde (IM)
Délai: Procédure post-index à 1, 6, 12 mois et 2, 3 et 5 ans
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Procédure post-index à 1, 6, 12 mois et 2, 3 et 5 ans
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Mort cardiaque ou infarctus du myocarde (IM)
Délai: Procédure post-index à 1, 6, 12 mois et 2, 3 et 5 ans
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Procédure post-index à 1, 6, 12 mois et 2, 3 et 5 ans
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Revascularisation de la lésion cible (TLR)
Délai: Procédure post-index à 1, 6, 12 mois et 2, 3 et 5 ans
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Procédure post-index à 1, 6, 12 mois et 2, 3 et 5 ans
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Revascularisation du vaisseau cible (TVR)
Délai: Procédure post-index à 1, 6, 12 mois et 2, 3 et 5 ans
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Procédure post-index à 1, 6, 12 mois et 2, 3 et 5 ans
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Device success
Délai: Hospital Discharge (6-24 hours post-index procedure)
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Device success, defined as attainment of < 30% residual stenosis of the target lesion (based on operator visual estimate) using the Orsiro Mission study stent only. |
Hospital Discharge (6-24 hours post-index procedure)
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Procedure success
Délai: Hospital Discharge (6-24 hours post-index procedure)
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Procedure success, defined as attainment of < 30% residual stenosis of the target lesion (based on operator visual estimate) using the Orsiro Mission study stent only without occurrence of in-hospital major adverse cardiac events (MACE). |
Hospital Discharge (6-24 hours post-index procedure)
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Major cardiac adverse events (MACE) and individual MACE components
Délai: 1, 6, 12 months and 2, 3, and 5 years post-index procedure
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MACE is defined as a composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically driven target lesion revascularization (TLR). |
1, 6, 12 months and 2, 3, and 5 years post-index procedure
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Target lesion failure (TLF) and individual TLF components
Délai: 1, 6, 12 months and 2, 3, and 5 years post-index procedure
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TLF is defined as a composite of cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR). |
1, 6, 12 months and 2, 3, and 5 years post-index procedure
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Target vessel failure (TVF) and individual TVF components
Délai: 1, 6, 12 months and 2, 3, and 5 years post-index procedure
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TVF is defined as a composite of cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (TV-MI), and clinically driven target vessel revascularization (CD-TVR). |
1, 6, 12 months and 2, 3, and 5 years post-index procedure
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Stent thrombosis
Délai: 1, 6, 12 months and 2, 3, and 5 years post-index procedure
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Stent thrombosis will be assessed according to Academic Research Consortium - 2 (ARC-2) definitions. |
1, 6, 12 months and 2, 3, and 5 years post-index procedure
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- G240288
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
No IPD sharing is planned at this time. This study evaluates an investigational device under an FDA IDE. The sponsor may consider sharing de-identified IPD under controlled access following completion of primary endpoint analysis and regulatory review. Summary results will be reported in scientific publications and public registries.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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