Comparison of RA-IVL and RA-SHP in Calcified Coronary Lesions

NCT07279987 | Not Yet Recruiting DMC

• 1 other identifier: 2025-ke-874
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Vascular Calcification

Keywords

Coronary Artery Disease; Percutaneous Coronary Intervention; Vascular calcification; Rotational atherectomy; Intravascular lithotripsy; Super high-pressure balloon; Major adverse cardiovascular events; Plaque modification

Outcome Measures

Primary Outcomes (1)

• Minimum Lumen Diameter (MLD) assessed by intravascular imaging

  The primary efficacy endpoint is the post-procedural minimum lumen diameter (MLD) measured by intravascular imaging (OCT or IVUS) immediately after stent implantation and final post-dilatation. MLD is defined as the smallest luminal diameter within the treated segment. An increase of ≥0.5mm compared to baseline MLD is considered clinically meaningful improvement. The measurement will be performed by the core imaging laboratory using standardized acquisition and analysis protocols with blinded adjudication.

  Immediately post-procedure (within 24 hours after PCI completion)

Secondary Outcomes (8)

• Acute lumen gain assessed by intravascular imaging

  Immediately post-procedure (within 24 hours after PCI completion)

• Final stent expansion rate assessed by intravascular imaging

  Immediately post-procedure (within 24 hours after PCI completion)

• Major Adverse Cardiovascular Events (MACE) at 30 days

  30 days post-procedure

• Major Adverse Cardiovascular Events (MACE) at 6 months

  6 months post-procedure

• Major Adverse Cardiovascular Events (MACE) at 12 months

  12 months post-procedure

Study Arms (2)

Rotational Atherectomy + Super High-Pressure Balloon

EXPERIMENTAL

Patients with severely calcified coronary lesions undergo rotational atherectomy followed by super high-pressure balloon angioplasty (SHPB) for calcium modification, then drug-eluting stent implantation with intravascular imaging guidance

Device: Super High-Pressure Non-Compliant Balloon

Rotational Atherectomy + Intravascular Lithotripsy

ACTIVE COMPARATOR

Patients with severely calcified coronary lesions undergo rotational atherectomy followed by intravascular lithotripsy (IVL) for calcium modification, then drug-eluting stent implantation with intravascular imaging guidance

Device: Intravascular Lithotripsy System

Interventions

Super High-Pressure Non-Compliant Balloon DEVICE

The super high-pressure balloon is a non-compliant balloon catheter capable of withstanding inflation pressures up to 35-40 atmospheres. The balloon is sized 1:1 to the reference vessel diameter and positioned across the calcified lesion. Inflation follows a stepwise pressure escalation protocol: 12 atm → 20 atm → 25 atm → 30 atm → 35 atm, with each pressure level maintained for 10-20 seconds. The high-pressure inflation creates controlled fractures in calcified plaque to facilitate subsequent stent deployment and expansion. The device is specifically designed for modification of severely calcified coronary lesions.

Also known as: SHPB, Ultra-High Pressure Balloon, Non-Compliant Balloon (rated to 35-40 atm), OPN NC Balloon

Rotational Atherectomy + Super High-Pressure Balloon

Intravascular Lithotripsy System DEVICE

The intravascular lithotripsy (IVL) system is a balloon-based catheter device that delivers sonic pressure waves to fracture calcium in coronary arteries. The IVL balloon is sized 1:1 to the reference vessel diameter and positioned across the calcified lesion. Once inflated to 4 atm, the system delivers up to 80 pulses of localized pulsatile mechanical energy (50 Hz) to create circumferential and longitudinal calcium fractures in both superficial and deep calcium layers. Each treatment cycle consists of 10 pulses over 10 seconds. The device is specifically designed to modify severe coronary calcification to facilitate stent delivery and expansion.

Also known as: IVL, Coronary Intravascular Lithotripsy, Sonic Pressure Wave Lithotripsy, Shockwave Coronary IVL System

Rotational Atherectomy + Intravascular Lithotripsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Acute myocardial infarction (AMI) within 7 days, as condition may be unstable and increase periprocedural complication risk
• 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
• Previous treatment history: previous stent implantation or rotational atherectomy in the same target vessel, as complex lesion structure or confounding treatment effects may exist
• 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)
• Pregnancy or lactation: pregnant or lactating women, as intraoperative radiation and drug effects may adversely affect mother and child
• Participation in other clinical trials: patients simultaneously participating in other interventional clinical trials, to avoid mutual influence of different trial intervention measures

Sponsors & Collaborators

• Lin Zhao: lead
• China-Japan Friendship Hospital: collaborator
• Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Beijing Chaoyang Hospital，Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Related Publications (3)

• Guedeney P, Claessen BE, Mehran R, Mintz GS, Liu M, Sorrentino S, Giustino G, Farhan S, Leon MB, Serruys PW, Smits PC, von Birgelen C, Ali ZA, Genereux P, Redfors B, Madhavan MV, Ben-Yehuda O, Stone GW. Coronary Calcification and Long-Term Outcomes According to Drug-Eluting Stent Generation. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1417-1428. doi: 10.1016/j.jcin.2020.03.053.

  PMID: 32553329 RESULT

• Hemetsberger R, Abdelghani M, Toelg R, Mankerious N, Allali A, Garcia-Garcia HM, Windecker S, Lefevre T, Saito S, Slagboom T, Kandzari D, Koolen J, Waksman R, Richardt G. Impact of Coronary Calcification on Clinical Outcomes After Implantation of Newer-Generation Drug-Eluting Stents. J Am Heart Assoc. 2021 Jun 15;10(12):e019815. doi: 10.1161/JAHA.120.019815. Epub 2021 May 29.

  PMID: 34056911 RESULT

• De Maria GL, Scarsini R, Banning AP. Management of Calcific Coronary Artery Lesions: Is it Time to Change Our Interventional Therapeutic Approach? JACC Cardiovasc Interv. 2019 Aug 12;12(15):1465-1478. doi: 10.1016/j.jcin.2019.03.038.

  PMID: 31395217 RESULT

MeSH Terms

Conditions

Vascular Calcification; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Lin Zhao, Dr

  Beijing Chaoyang Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinyue Yang, Dr

CONTACT

+8613592641432; 1732583186@qq.com

Yuan Fu, Dr

CONTACT

+8613641341747; 13641341747@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cheif of Cardiovascular department

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)