Intravascular Lithotripsy Versus Rotational Atherectomy for Severe Coronary Artery Calcification: A Prospective, Multicenter, Non-inferiority Randomized Controlled Trial (LIRAC)
Severely calcified coronary lesions represent one of the major challenges in interventional cardiology. Severe coronary calcification increases the difficulty and complexity of percutaneous coronary intervention (PCI), impedes device delivery, and may even lead to device failure. Moreover, stent underexpansion further elevates the risks of cardiac death, myocardial infarction, target vessel revascularization, and in-stent thrombosis. Rotational atherectomy (RA) is an effective modality for treating severely calcified coronary lesions, as it adequately modifies calcific plaques, facilitates luminal enlargement, and improves device deliverability. However, RA fragments calcific plaques into microparticles that are subsequently cleared by the reticuloendothelial system in the distal microvasculature, potentially inducing microvascular dysfunction.
In recent years, intravascular lithotripsy (IVL) has emerged as an innovative calcium-modification technique in clinical practice. This technology employs acoustic pressure waves to selectively disrupt deep-seated calcific plaques, inducing fractures within the calcium while sparing the soft tissue of the vessel wall from substantial injury. IVL is performed with low-pressure balloon inflation (4-6 atm), which helps to minimize the risk of vascular injury; its mechanism of action does not produce macroscopic debris, theoretically obviating distal embolization and associated microcirculatory disturbances. Recently published prospective observational studies-the REPLICA-EPIC18 and BENELUX-IVL registries-have demonstrated that IVL is feasible and safe in "real-world" severely calcified lesions, effectively facilitating stent implantation.
Although both RA and IVL are important tools for managing severe calcific lesions, there remains a paucity of high-level, head-to-head evidence directly comparing post-procedural minimal stent area between the two modalities. Clarifying this issue is of significant clinical importance for guiding clinicians in selecting optimal revascularization strategies tailored to distinct pathological characteristics and patient profiles, thereby improving procedural safety and patient outcomes. To this end, we plan to conduct a prospective, multicenter, randomized clinical trial (RCT) aimed at comparing the minimal stent area between intravascular lithotripsy and rotational atherectomy in patients with severely calcified lesions.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jun Jiang, MD, PhD
- 電話番号：86-571-8778-3992
- メール：jiang-jun@zju.edu.cn
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:
- Age ≥ 18 years;
- Target lesion with diameter stenosis ≥ 50% (visual estimation) associated with evidence of myocardial ischemia;
- Target lesion must be a de novo, in-situ severely calcified coronary lesion, where severe calcification is defined as: radiopacity visible prior to contrast injection and in the absence of cardiac pulsation, typically involving both sides of the vessel wall; and ≥270° circumferential calcification as evidenced by intravascular ultrasound (IVUS);
- Target vessel reference diameter between 2.5 and 4.0 mm, with successful guidewire traversal;
- A maximum of two non-target lesions requiring interventional treatment, which must be successfully treated prior to the target lesion;
- Patients presenting with evidence of symptomatic or asymptomatic myocardial ischemia, stable or unstable angina pectoris, or prior myocardial infarction;
- Signed written informed consent obtained.
Exclusion Criteria:
- Cardiogenic shock or hemodynamic instability;
- Chronic total occlusion (CTO);
- Requirement for intraprocedural mechanical circulatory support, such as intra-aortic balloon pump (IABP) or Impella device;
- Acute ST-segment elevation myocardial infarction (STEMI) occurring within 1 month prior to enrollment;
- Angiographically visible thrombus at the target lesion site;
- Left main ostial lesion with stenosis ≥ 50%;
- Left ventricular ejection fraction (LVEF) < 40%;
- New-onset stroke or transient ischemic attack (TIA) within 90 days;
- Bypass graft lesion;
- Coronary artery dissection of type B or greater (NHLBI classification);
- Pregnant or lactating patients;
- Life expectancy < 1 year;
- Active bleeding;
- Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m²;
- Presence of cognitive or psychiatric disorders, as confirmed by clinical diagnosis or investigator assessment;
- Illiteracy, semi-literacy, or any visual impairment, reading/writing disability that prevents the patient from independently reading the patient information sheet and personally providing written informed consent without assistance.
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 |
|---|---|
|
アクティブコンパレータ：Intravascular lithotripsy group
IVL:Intravascular lithotripsy (IVL) balloon is used to dilate severely calcified plaques.
Pre-dilatation with a balloon ≤2.0 mm is permitted.
Intravascular ultrasound (IVUS) with automated pullback must be performed both after lithotripsy and at the end of the procedure
|
The procedure entails the use of a lithotripsy balloon for dilation of severely calcified plaques.
Pre-dilatation may be performed with a balloon up to 2.0 mm in diameter.
Intravascular ultrasound (IVUS) with automated pullback is mandatory immediately following lithotripsy and upon completion of the procedur
|
|
アクティブコンパレータ：Rotational atherectomy group
RA:The procedure involves using a rotational atherectomy burr to modify severely calcified plaques.
After the burr has traversed the lesion, three to five additional polishing runs are required to achieve optimal plaque modification.
If 1:1 balloon dilatation at the target lesion is performed with satisfactory expansion, rotational atherectomy is terminated.
Intravascular ultrasound (IVUS) with automatic pullback must be performed both immediately after rotational atherectomy and at the end of the procedure
|
The procedure involves using a rotational atherectomy burr to modify severely calcified plaques.
After the burr has traversed the lesion, three to five additional polishing runs are required to achieve optimal plaque modification.
If 1:1 balloon dilatation at the target lesion is performed with satisfactory expansion, rotational atherectomy is terminated.
Intravascular ultrasound (IVUS) with automatic pullback must be performed both immediately after rotational atherectomy and at the end of the procedure.
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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 |
時間枠 |
|---|---|
|
minimal stent area
時間枠：Within one hour post-percutaneous coronary intervention
|
Within one hour post-percutaneous coronary intervention
|
その他の成果指標
結果測定 |
時間枠 |
|---|---|
|
標的船舶の故障
時間枠：1年
|
1年
|
|
major adverse cardiac event
時間枠：1 year
|
1 year
|
|
success rate of PCI
時間枠：Within one hour post-percutaneous coronary intervention
|
Within one hour post-percutaneous coronary intervention
|
|
complications during perioperative period
時間枠：during perioperative period
|
during perioperative period
|
|
IVUS image feature analysis
時間枠：Within one hour post-percutaneous coronary intervention
|
Within one hour post-percutaneous coronary intervention
|
|
TnT+CK/CKMB
時間枠：24 hours post-PCI
|
24 hours post-PCI
|
|
The dosage of contrast agent, the amount of X-rays exposed and the operation time
時間枠：during the PCI
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during the PCI
|
|
Subgroup analysis of gender, age, diabetes, etc
時間枠：1 year
|
1 year
|
|
The differences and influences of computational physiology and microcirculation between the two groups of patients
時間枠：1 year
|
1 year
|
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
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