NCT07279987Toborzás még nem indult
Comparison of RA-IVL and RA-SHP in Calcified Coronary Lesions
Comparison of Combined Rotational Atherectomy With Intravascular Lithotripsy Versus Super-High Pressure Balloon Angioplasty for Heavily Calcified Coronary Lesions (CRUSH-CALC Study)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 29.
Rövid összefoglaló (regiszter, angolul)
Study Design Prospective, multicenter, single-blind, randomized controlled trial Hypothesis In patients with severely calcified coronary lesions undergoing rotational atherectomy (Rota), post-rotational lesion optimization using intravascular lithotripsy (IVL) is non-inferior to super high-pressure balloon (SHPB) in terms of final minimal lumen diameter (MLD), with potential differences in acute lumen gain, stent expansion, and periprocedural complications. Inclusion Criteria * Age ≥ 18 years * De novo coronary lesions with severe calcification confirmed by angiography (moderate-to-severe calcification) and IVUS (calcification grade ≥2 by Mintz classification, or IVUS cannot pass) * Target vessel reference diameter 2.5-4.0 mm * Lesion length ≤ 30 mm suitable for rotational atherectomy * Clinical evidence of ischemia (stable or unstable angina, or functional ischemia testing) * Planned rotational atherectomy with residual calcification grade ≥2 post-Rota (burr ≤1.5 mm), or inadequate expansion with 2.5 mm non-compliant balloon at nominal pressure * Written informed consent provided Exclusion Criteria * Acute myocardial infarction within 7 days * Presence of thrombus, chronic total occlusion (CTO), or in-stent restenosis in target vessel * Lesion located in coronary artery bypass graft * Severe heart failure (LVEF < 30%) * Previous stenting or rotational atherectomy in same target vessel * Known contrast allergy, active bleeding, severe comorbidity with life expectancy < 12 months * Pregnancy or lactation * Participation in other interventional clinical trials Randomization After initial rotational atherectomy (burr ≤1.5 mm), eligible patients meeting imaging-defined "need for further lesion optimization" criteria will be randomized 1:1 to: Rota + IVL group: Intravascular lithotripsy using pulsed ultrasonic energy (up to 80 pulses, 8 cycles) followed by stent implantation Rota + SHPB group: Super high-pressure balloon (≥30 atm) expansion followed by stent implantation Stratification by: Study center, Reference vessel diameter (2.5-3.0 mm vs. >3.0-4.0 mm) Primary Endpoint Post-procedural minimal lumen diameter (MLD) measured by OCT/IVUS immediately after stent implantation and post-dilation Secondary Endpoints Procedural efficacy: Acute lumen gain, final stent expansion rate, minimal stent area, stent apposition Procedural safety: Periprocedural complications including coronary perforation, dissection, no-reflow/slow flow, acute stent thrombosis Clinical outcomes: MACE (composite of cardiac death, myocardial infarction, target vessel revascularization) at 30 days, 6 months, and 12 months Other outcomes: Major bleeding (BARC ≥2), acute kidney injury (KDIGO criteria), procedure duration, contrast volume, radiation exposure Sample Size Total: 162 patients (81 per group) In-hospital monitoring until discharge Clinical follow-up at 30 days, 6 months, and 12 months Imaging follow-up (OCT/IVUS) selectively at designated centers as per protocol or clinical indication Study Centers Three tertiary hospitals with extensive experience in complex coronary interventions and calcified lesion management: * Beijing Chaoyang Hospital, Capital Medical University (coordinating center) * China-Japan Friendship Hospital * Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Study Duration January 2026 to December 2028 (3 years)
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 162 (tervezett)
- Első benyújtás
- 2025. dec. 1.
- Kezdés
- 2026. jan. 1.
- Elsődleges befejezés
- 2027. dec. 31.
- Fő szponzor
- Lin Zhao
- Betegségek
- Koszorúér-betegség
- NCT-szám
- NCT07279987
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 162
- 2026. jan. 1. és az elsődleges befejezés (2027. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Previous treatment history: previous stent implantation or rotational atherectomy in the same target vessel, as complex lesion structure or confounding treatment effects may exist
- Pregnancy or lactation: pregnant or lactating women, as intraoperative radiation and drug effects may adversely affect mother and child
Más betegség
- Acute myocardial infarction (AMI) within 7 days, as condition may be unstable and increase periprocedural complication risk
- Special medical history: Known contrast allergy or severe bleeding tendency (such as active gastrointestinal bleeding), may be unable to tolerate PCI surgery; Patients with other serious comorbidities, expected to be unable to complete 12-month follow-up (such as life expectancy <12 months)
Laborértékek
- Target vessel characteristics: Target vessel with thrombus formation, may increase intraoperative embolism risk; Target vessel with chronic total occlusion (CTO), unable to be treated by rotational atherectomy and calcium modification techniques; Target lesion is in-stent restenosis; Target lesion located in coronary artery bypass graft
- Severe heart failure: left ventricular ejection fraction <30%, poor tolerance to PCI surgery, may increase perioperative mortality risk
Egyéb
- Participation in other clinical trials: patients simultaneously participating in other interventional clinical trials, to avoid mutual influence of different trial intervention measures
Kiket keres a vizsgálat
- Age ≥18 years, able to understand the study purpose and voluntarily sign written informed consent
- Coronary angiography confirmed severe calcified lesions (Mintz classification ≥Grade 2), with IVUS unable to pass or showing calcification grade ≥2
- Native coronary artery lesion
- Target vessel diameter 2.5-4.0mm
- Lesion length ≤30mm, suitable for rotational atherectomy
- Clinical indication for PCI: Ischemic cardiomyopathy confirmed by functional testing (e.g., myocardial nuclear scan); Clinical presentation of stable or unstable angina with clear PCI indication
- Planned rotational atherectomy as initial calcium modification technique
- After rotational atherectomy (burr diameter ≤1.5mm), IVUS shows calcification grade still ≥2, or <2 but 2.5mm non-compliant balloon cannot achieve adequate expansion at nominal pressure
- Informed consent signed and agreement to participate in clinical trial
- Able to comply with treatment and complete follow-up
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Beijing Chaoyang Hospital, Capital Medical University | Beijing | Kína | Ismeretlen állapot |
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