Coronary Computed Tomography Angiography (CCTA) for the Pre-procedural Planning of Percutaneous Coronary Intervention (CT-PLAN-PCI)
Coronary Computed Tomography Angiography (CCTA) for the Pre-procedural Planning of Percutaneous Coronary Intervention: A Randomized Trial of Routine PCI Versus CCTA-guided PCI
調査の概要
詳細な説明
CCTA provides comprehensive anatomical characterization of coronary arteries, including plaque morphology. It allows assessment of the origin and course of the coronaries, proximal and distal reference vessel dimensions, which can inform landing zones for stent length selection, and stent sizing. CCTA also enables comprehensive physiological assessment through fractional flow reserve (FFRCT), including FFRCT pullback for disease pattern characterization and delta FFRCT. In addition, CCTA can estimate vessel-specific myocardial mass to support bifurcation PCI planning and may assist intra-procedural guidance through CT co-registration. Whether CCTA-guided PCI is non-inferior to an intravascular ultrasound (IVUS) guided PCI strategy is being evaluated in the Precise Procedural and PCI Plan (P4) randomized clinical trial (NCT05253677). P4 enrolled approximately 1,100 patients and is evaluating the incidence of major adverse cardiovascular events (cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization) between CT- and IVUS-guided PCI at 12-months. While this landmark trial is expected to provide the first randomized data to support CT-guided PCI, broader clinical adoption remains limited by the need for multiple software platforms and investigational applications.
While promising, there are limited prospective and/or randomized data showing that CT-guided PCI is superior to standard of care. Early U.S. experience using coronary computed tomography angiography (CCTA) for percutaneous coronary intervention (PCI) planning highlighted the emerging role of CCTA to inform case complexity, equipment utilization, lesion morphology and non-invasive coronary physiology. Despite these promising findings, these studies were small, single-center, and non-controlled. To demonstrate clinical value, a randomized controlled trial comparing CCTA guided PCI with standard PCI would be necessary to determine whether this approach yields similar or superior outcomes in broader patient populations.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Minnesota
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Minneapolis、Minnesota、アメリカ、55407
- Minneapolis Heart Institute Foundation
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主任研究者：
- Yader Sandoval, MD
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コンタクト：
- Olga Mastrodemos
- 電話番号：612-863-4768
- メール：olga.mastrodemos@allina.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- At least one moderate-severe coronary stenosis on CCTA with an FFRCT ≤0.80 involving no more than two vessels (i.e. target lesion(s) must be FFRCT eligible)
- Referral for non-emergent PCI of at least one de novo stenosis in a native coronary artery with a reference diameter ≥2 mm on CCTA.
Exclusion Criteria:
- Multivessel CAD involving ≥3 vessels.
- Severe left main disease >50%
- Prior CABG
- Prior PCI in target vessel
- Planned CABG
- Chronic coronary total occlusion in the target vessel
- ST-elevation myocardial infarction
- Emergent PCI
- Cardiac arrest
- Cardiogenic shock
- Scenarios where FFRCT is not possible: inadequate CCTA quality for FFRCT, small vessels <2 mm, with stents at the target vessel.
- Unstable high-risk NSTE-ACS (hemodynamic instability, refractory angina, unstable arrhythmias, persistent ischemia).
- Patients who are pregnant or nursing or plan to be pregnant in the period up to 2 years following the index procedure will not be approached due to exposure to fluoroscopy.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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：CT-guided PCI
Pre-procedural planning will be completed using the participant's CT, and tools including Heartflow's PCI Navigator
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Participants randomized to CT-guided PCI will have their clinically available CCTAs analyzed using commercially available software to create a pre-procedural plan, which will be used to help guide the procedure
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アクティブコンパレータ：Routine PCI
Participants randomized to this arm will undergo standard-of-care PCI without pre-procedural planning based on CT
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Participants randomized to routine PCI will not have their CCTA's analyzed pre-procedure.
The investigator may use intravascular imaging and pre-PCI FFR, but these are not mandated.
The investigator will use the information obtained from the coronary angiogram to treat any coronary artery disease that is present.
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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 |
|---|---|---|
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Procedural time
時間枠：intra-procedural
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procedural time, defined as the time between the first to the final angiographic image acquisition
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intra-procedural
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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 |
|---|---|---|
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Contrast volume
時間枠：intra-procedural
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The volume of contrast used during the index procedure
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intra-procedural
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Radiation dose
時間枠：intra-procedural
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The dose of radiation used during the index procedure
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intra-procedural
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Fluoroscopy time
時間枠：intra-procedural
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The amount of time during the procedure that fluoroscopy was used
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intra-procedural
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Post-PCI pressure wire based FFR
時間枠：intra-procedural
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Measured as a blinded investigational endpoint after the final angiographic image and not included in procedural time
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intra-procedural
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Use of advanced calcium modification techniques
時間枠：intra-procedural
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intra-procedural
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Resource utilization
時間枠：intra-procedural
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number of diagnostic or guide catheters used, equipment usage throughout the case
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intra-procedural
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PCI Complications and Incidence of MACE During Index Procedure
時間枠：intra-procedural
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incidence of major adverse cardiac events during the index procedure
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intra-procedural
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Peri-procedural myocardial injury and infarction
時間枠：Peri-procedural
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Incidence of myocardial injury and infarction after the index procedure, during hospitalization
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Peri-procedural
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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。
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