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Rotational atherectomy combined with cutting balloon for treatment of severely calcified coronary lesions

Safety andefficacy of rotational atherectomy combined with cutting balloon for treatment of severely calcified coronary lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-ICR-15007200
Enrollment
Unknown
Registered
2015-10-06
Start date
2015-12-01
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 artery disease

Interventions

trail group:rotational artherectomy combined with cutting balloon
control group:rotational artherectomy

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. consecutive patients age between 18 years and90 years; 2. the stenosis of target lesions is more than 50% evaluated by coronary angiography; 3. the target lesions are severely calcified one evaluated by intravascular ultrasound (superfical calcification andthe calcified arc is more than 180 degree).

Exclusion criteria

Exclusion criteria: 1. target lesion is in-stent restenosis; 2. the target lesion is in vein grafts; 3. the target lesion with obvious dissection before predilatation; 4. the target lesion with extremely tortuous angle; 5. patients with serious arrthymia caused unstable haemodynamic; 6. patients with serious infection; 7. patients with tumor andlife expentancy is less than 2 years; 8. patients with active bleeding; 9. patients with serious renal insufficiency.

Design outcomes

Primary

MeasureTime frame
minimum stent area;acute lumen gain after stent;major cardiac event at 1 year;major cardiac event at 2 year;

Countries

China

Contacts

Public ContactYu Wang
wangyu301@163.com+86 13701246810

Outcome results

None listed

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