Opsens Optowire for Fractional Flow Reserve - The O2 Pilot Study (O2)
調査の概要
詳細な説明
Fractional flow reserve (FFR) measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery. An FFR of 1.0 is widely accepted as normal. An FFR value lower than 0.75 - 0.80 is generally considered to be associated with myocardial ischemia (MI).
FFR is easily measured during routine coronary angiography by using a pressure wire to calculate the ratio between coronary pressure distal to a coronary artery stenosis and aortic pressure under conditions of maximum myocardial hyperemia. This ratio represents the potential decrease in coronary flow distal to the coronary stenosis.
Over the past decade, FFR measurement has been increasingly used in cardiac catheterization laboratories. It provides a quantitative assessment of the functional severity of a coronary artery stenosis identified during coronary angiography and cardiac catheterization.
Opsens, Inc. has developed a new pressure wire for use in determining FFR in coronary arteries; the OptoWire. The OptoWire is an instrumented guide wire with a fiber optic pressure sensor mounted 3.5 cm proximal to the tip. The Optowire measures blood pressure during diagnostic and/or interventional procedures when used in combination with the OptoMonitor.
The O2 study is a pilot study which aims to provide preliminary experience in human patients with coronary artery disease. The study data will also be used as part of design validation.
The O2 study is a prospective single arm study designed to assess the usability, functionality, and safety of the Optowire and Optomonitor in patients.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
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Quebec、カナダ、G1V 4G5
- IUCPQ - Laval Hospital
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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
説明
Inclusion Criteria:
Patients with
- Stable angina or,
- Unstable angina pectoris or,
- Atypical chest pain or no chest pain but with suspected ischemia
- At least one moderate lesion in native coronary artery thought to produce ischemia
- Operator and patient agree for procedures
- Patient (> 18 years) has signed a written informed consent prior to procedure
Exclusion Criteria:
- Lesions with angiographic 'haziness' or suspected to contain thrombus
- Post-coronary artery bypass grafting
- Total occlusion
- If use of atherectomy device is indicated
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
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Fractional flow reserve
Fractional flow reserve measurement
|
Fractional flow reserve measurement
他の名前：
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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 |
|---|---|---|
|
Safety and handling assessment of the Optowire
時間枠：Patients will be followed through removal of the OptoWire from percutaneous insertion site and completion of the cardiac catheterization procedure (expected average <1hr)
|
Dedicated questionnaires will be used for such assessment |
Patients will be followed through removal of the OptoWire from percutaneous insertion site and completion of the cardiac catheterization procedure (expected average <1hr)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Comparison of FFR values measured with Optowire vs. with FFR guide wire used in standard practice
時間枠：Patients will be followed through removal of the OptoWire from percutaneous insertion site and completion of the cardiac catheterization procedure (expected average <1hr)
|
In selected cases, the operator may choose to perform FFR measurements using currently approved FFR wires.
Values obtained with standard FFR wires and Optowire may therefore be compared.
|
Patients will be followed through removal of the OptoWire from percutaneous insertion site and completion of the cardiac catheterization procedure (expected average <1hr)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Olivier F Bertrand, MD PhD、International Chair on Interventional Cardiology and Transradial Approach
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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。