BioFreedom French Registry
A Post-Market Registry of the BioFreedomTM Biolimus A9TM Coated Coronary Stent System
Prospective, observational multi-center registry to be conducted at up to 25 French interventional cardiology centers. Patients will be eligible once they have received at least one BioFreedomTM DCS as per standard clinical practice and will be followed for up to 2 years post PCI for data collection.
The purpose of the registry is to explore the safety and effectiveness of the BioFreedomTM DCS in standard clinical practice in France and to serve as part of Post Market Surveillance.
調査の概要
状態
条件
詳細な説明
Prospective, observational multi-center registry to be conducted at up to 25 French interventional cardiology centers. Patients will be eligible once they have received at least one BioFreedomTM DCS as per standard clinical practice and will be followed for up to 2 years post PCI for data collection.
The registry will be purely observational and will not interfere with physician's decisions relating to stent selection or indication for treatment.
The purpose of the registry is to explore the safety and effectiveness of the BioFreedomTM DCS in standard clinical practice in France and to serve as part of Post Market Surveillance.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
-
Fontaine-lès-Dijon、フランス、21121
- Clinique de Fontaine
-
Haguenau Cedex、フランス、67504
- Centre Hospitalier General
-
Pessac、フランス、33600
- Clinique Saint Martin
-
Toulouse、フランス
- CHU Toulouse Rangeuil
-
-
Cedex 2
-
Clermont-ferrand、Cedex 2、フランス、63050
- Clinique Des Dômes
-
-
Essonne
-
Quincy sous Sénart、Essonne、フランス、91480
- at Hôpital Privé Claude Galien ICPS
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients treated with one or more BioFreedom™ DCS .Patients who agree to comply with the follow up requirements. .Patients with a life expectancy of > 1 year at time of consent. .Patients eligible to receive dual anti platelet therapy (DAPT).
- Patients who have signed an Informed Consent
Exclusion Criteria:
- Patients unable or unwilling to give documented informed consent
- Patients taking part in another interventional trial which has not completed follow-up for the primary endpoint .Patient has received an additional stent different from a BioFreedom™ DCS stent during the index procedure.
- Pregnant or breastfeeding women
- Planned surgery within 6 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri surgical period for non HBR patients
- Planned surgery within 1 month of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri surgical period for HBR patients
- Patients under judicial protection, tutorship or curatorship
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
DOCE
時間枠：1 year
|
Device-oriented composite endpoint (DOCE) at 12 months defined as composite of cardiovascular death (CD), myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically driven target lesion revascularization (cd-TLR).
|
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
All-cause mortality
時間枠：12-month and 24-month
|
1. All-cause mortality, CD, non-cardiovascular and undetermined death in hospital and at 12 and 24 months
|
12-month and 24-month
|
|
Patient-oriented composite endpoint (POCE) at 12 and 24 months
時間枠：12 months and 2 years
|
Patient-oriented composite endpoint (POCE) at 12 and 24 months defined as all-cause mortality, any stroke, any MI (including nontarget vessel territory) and any revascularization.
|
12 months and 2 years
|
|
Composite of Cardiovascular Death (CD) at 12 and 24 months
時間枠：12 months and 2 years
|
Composite of CD, MI and definite/probable stent thrombosis (ST) at 12 and 24 months.
|
12 months and 2 years
|
|
Definite/probable ST at 12 and 24 months
時間枠：12 months and 24 months
|
Definite/probable ST at 12 and 24 months
|
12 months and 24 months
|
|
Target Vessel Failure defined at 12 and 24 months
時間枠：12 months and 24 months
|
Target Vessel Failure (TVF) defined as CD, target-vessel-related MI, and Target vessel revascularization (TVR) at 12 and 24 months
|
12 months and 24 months
|
|
Target Lesion Failure at 12 and 24 months
時間枠：12 months and 24 months
|
Target Lesion Failure (TLF) defined as CD, target-vessel-related MI, and clinically driven TLR at 12 and 24 months
|
12 months and 24 months
|
|
Clinically driven TLR at any follow-up time point
時間枠：Inclusion, 12 months and 24 months
|
Clinically driven TLR at any follow-up time point
|
Inclusion, 12 months and 24 months
|
|
Clinically driven TVR at any follow-up time point
時間枠：Inclusion, 12 months and 24 months
|
Clinically driven TVR at any follow-up time point
|
Inclusion, 12 months and 24 months
|
|
Any revascularization
時間枠：within 24 months following the index procedure
|
Any revascularization within 24 months following the index procedure, unless they are planned within the 1st month
|
within 24 months following the index procedure
|
|
Stroke, disabling and non-disabling.
時間枠：Inclusion, 12 months and 24 months
|
Stroke, disabling and non-disabling.
|
Inclusion, 12 months and 24 months
|
|
BARC 3 to 5 bleeding
時間枠：Inclusion, 12 months and 24 months
|
BARC 3 to 5 bleeding
|
Inclusion, 12 months and 24 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Janusz Lipiecki, MD、Clinique Des Dômes
- 主任研究者：Philippe Garot, MD、ICPS, Massy
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
冠動脈疾患の臨床試験
-
Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ