Italian Absorb Registry (BVS-RAI)
Clinical Study on Absorb Polylactic, Reabsorbable Coronary Scaffold (RAI)
調査の概要
詳細な説明
Long-term data after implantation of coronary BVS is scarce, especially in subgroups of patients with diabetes or chronic kidney disease, and in those with complex coronary lesions and/or multivessel disease.
Although the use of BVS is very promising in younger patients with one or more of the above characteristics, evidence of benefit is not available.
The BVS-RAI Registry is a spontaneous initiative of a group of Italian interventional cardiologists who are interested in assessing the results of their interventional practice with BVS, by sharing data.
The BVS-RAI Registry has been created in joint-venture with Centro di Ricerche Farmacologiche e Biomediche "Mario Negri Sud", and is not recipient of funding or benefits originating from the BVS manufacturer or seller. BVS devices are regularly purchased by the participating centres.
Each participating centre is willing to input data of all consecutive patients treated with BVS, with a minimum of 50, and to report on follow-up for at least 5 years. Patient recruitment is not directed per protocol, nor is it rewarded. Patients who give informed consent are included in the BVS-RAI Registry after BVS implant has been performed following the indications, techniques and protocols used in each of the participating institutions.
Baseline patient clinical data, with special attention to biochemistry and drug treatment in patients with diabetes and CKD, as well as angiographic and intravascular imaging data are entered into a web-based Case Report Form.
Follow-up data from outpatient visits or phone interviews, subsequent admissions and coronary angiograms following the protocols being used in each of the participating institutions are prospectively collected and entered into the database.
All data in the CRF is visible to all registered participants at all times. Endpoints are: target lesion and target vessel failure, BVS thrombosis, new revascularisation, myocardial infarction and death. Documentation of those events is required for adjudication by an independent committee.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Cuneo、イタリア
- SSD Emodinamica Dip Cardiovasc ASO S.Croce
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参加基準
適格基準
就学可能な年齢
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:
- Successful implantation of 1 or more coronary BVS
- Age <75 years
- Patient's informed consent
Exclusion Criteria:
- None
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 |
---|---|---|
Scaffold thrombosis
時間枠:1 year
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acute, subacute, late and very late
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1 year
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Target lesion revascularization
時間枠:1 year
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ischemia or angiographic-driven
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1 year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
MACE
時間枠:5 year
|
Cardiac death, TLR, myocardial infarction
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5 year
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協力者と研究者
協力者
捜査官
- 主任研究者:Alfonso Ielasi, MD、AO Seriate
- 主任研究者:Bernardo Cortese, MD、AO Fatebenefratelli
- 主任研究者:Donatella Corrado, PhD、Istituto di Ricerche Farmacologiche Mario Negri Milano
出版物と役立つリンク
一般刊行物
- Cortese B, Ielasi A, Moscarella E, Loi B, Tarantini G, Pisano F, Durante A, Pasquetto G, Colombo A, Tumminello G, Moretti L, Calabro P, Mazzarotto P, Varricchio A, Tespili M, Latini RA, Defilippi G, Corrado D, Steffenino G; RAI Investigators. Thirty-Day Outcomes After Unrestricted Implantation of Bioresorbable Vascular Scaffold (from the Prospective RAI Registry). Am J Cardiol. 2017 Jun 15;119(12):1924-1930. doi: 10.1016/j.amjcard.2017.03.017. Epub 2017 Mar 29.
- Cortese B, Ielasi A, Varricchio A, Tarantini G, LaVecchia L, Pisano F, Facchin M, Gistri R, D'Urbano M, Lucci V, Loi B, Tumminello G, Colombo A, Limbruno U, Nicolino A, Calzolari D, Tognoni G, Defilippi G, Buccheri D, Tespili M, Corrado D, Steffenino G; BVS-RAI investigators. Registro Absorb Italiano (BVS-RAI): an investigators-owned and -directed, open, prospective registry of consecutive patients treated with the Absorb BVS: study design. Cardiovasc Revasc Med. 2015 Sep;16(6):340-3. doi: 10.1016/j.carrev.2015.05.010. Epub 2015 Jun 3.
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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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
PCI with Absorb scaffoldの臨床試験
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Belfast Health and Social Care TrustBristol Royal Infirmary; Royal Infirmary of Edinburgh; Golden Jubilee National Hospitalわからない
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Yonsei University引きこもった
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Phillip FreemanOdense University Hospital; Aarhus University Hospital; Biosensors International; OrbusNeich積極的、募集していない