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Intensive plaque modification with rotational atherectomy and cutting balloon before drug-eluting stent implantation for patients with severely calcified coronary lesions

Intensive plaque modification with rotational atherectomy and cutting balloon before drug-eluting stent implantation for patients with severely calcified coronary lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16008274
Enrollment
Unknown
Registered
2016-04-12
Start date
2010-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Coronary calcification

Interventions

rotational atherectomy+cutting balloon (RA+CB):we pretreated severely calcified plaque with rotational atherectomy(RA), with pre-dilation of the lesion achieved with a cutting balloon(CB)
rotational atherectomy(RA):the calcified lesion was pretreated with rotational atherectomy(RA) and a conventional plain balloon was selected for subsequent pre-dilation

Sponsors

Sichuan Provincial People's Hospital, Sichuan Academy of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: These patients met the following inclusion criteria of the study: with at least one severe coronary stenosis >=70%, as indicated by angiography; with at least one severely calcified lesion of the target vessels, defined as a calcium arc of >=180 degree; and agreed to receive an RA or CB-based intensive modification of the plaque before PCI.

Exclusion criteria

Exclusion criteria: Patients were excluded from the current study for any of the following: acute thrombosis with unstable hemodynamic status requiring emergent PCI; previous PCI and presence of in-stent restenosis; extremely tortuous or angulated lesions or lesions with dissection before balloon expansion; lesion within a vein graft; or other complications or comorbidities which were contraindicated for angiography or PCI (e.g., severe renal dysfunction).

Design outcomes

Primary

MeasureTime frame
Min. stent cross sectional area(CSA);Acute CSA gain;Coronary dissection;Coronary perforation;Coronary slow flow or no-reflow;Stent thrombosis;Stent dislodgment;

Secondary

MeasureTime frame
myocardial infarction;Cardiovascular death;stroke;Target lesion revascularization;

Countries

China

Contacts

Public ContactQiyong Li

Department of Cardiology, Sichuan Provincial People’s Hospital, Sichuan Academy of Medical Science

18981838258@163.com+86 18981838258

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 13, 2026