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Rotational Atherectomy in Coronary Heart Disease Patients withDifferent Rotational Speed: In Hospital and twelve-Month Outcomes

Safety and Efficacy of Different Rotational Speed during Rotational Atherectomy in Coronary Heart Disease Patients (RACE)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076194
Enrollment
Unknown
Registered
2023-09-27
Start date
2023-10-01
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Atherosclerotic Heart Disease

Interventions

experimental group:Continuous low speed (LSRA) (140,000rpm)
experimental group:Continuous high speed (HSRA) (180,000rpm)
experimental group:High speed followed by low speed (HSRA+LSRA) (180,000rpm followed by 100,000rpm)

Sponsors

the First affiliated Hospital of USTC
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. Severe calcification of the coronary arteries as assessed by the semi-quantitative coronary calcification score; 3. Calcified lesions with an arc of more than 270° detected by IVUS; 4. IVUS finding of a calcified nidus that clearly protrudes into the lumen; 5. Calcification score of 4 on OCT assessment; 6. OCT findings of calcified nodules significantly protruding into the lumen; 7. Inability of the balloon to pass or to adequately dilate the lesion.

Exclusion criteria

Exclusion criteria: 1. Aged ? 80 years; 2. Combined severe left heart insufficiency [left ventricular ejection fraction (LVEF) <= 30%]; 3. Lesions that cannot be passed by a spinning mill guidewire; 4. Significantly thrombus-rich lesions; 5. Venous bridge vessel lesions; 6. Angle-forming lesions greater than 90°; 7. Severe spiral entrapment; 8. Rotational grinding immediately after stent placement; 9. Pregnant or lactating women; 10. Life expectancy ? 1 year; 11. Those who cannot cooperate with follow-up visits.

Design outcomes

Primary

MeasureTime frame
Intraoperative Complications of Rotational Abrasion;

Secondary

MeasureTime frame
Calcification ring fracture;Minimum luminal area of the target lesion;Major adverse cardiovascular events;Minimum lumen diameter of target lesion;Cardiac death in hospitalisation;Acute stent thrombosis during hospitalisation;Acute heart failure during hospitalisation;

Countries

China

Contacts

Public ContactWu Jiawei

The First affiliated Hospital of USTC

Wjwei626@163.com+86 138 5699 7469

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026