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Study on the popularization and application of rotational atherectomy for the treatment of severely calcified coronary lesions

Study on the popularization and application of rotational atherectomy for the treatment of severely calcified coronary lesions

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000029775
Enrollment
Unknown
Registered
2020-02-13
Start date
2020-02-12
Completion date
Unknown
Last updated
2020-02-17

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

Conditions

Coronary Artery Disease

Interventions

rotational atherectomy:rotational atherectomy
non rotational atherectomy:predilatation balloon

Sponsors

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The age of the subjects was >= 18 years old. Regardless of gender; 2. Subjects understand and sign informed consent; 3. Subjects have clinical indications for PCI / stent implantation; 4. Follow-up evaluation of subjects' willingness to comply with all requirements of the regimen; 5. Angiography / surgery inclusion criteria (subjects need to meet one of the following conditions): (1) The target lesion has visual severe calcification (severe calcification: an opaque site that occurs when there is no heartbeat before injection of contrast medium, It usually involves both sides of the arterial lumen; (2) Failure of balloon dilatation in target lesions 3 instruments (microcatheters, balloons or stents) cannot pass through the target lesions.

Exclusion criteria

Exclusion criteria: 1. The subjects had clinical symptoms and / or ECG (ECG) changes consistent with acute MI (including STEMI and NSTEMI) within 2 weeks. 2. The subjects had the following angiographic changes: (1) Thrombus in the target vessel (visual); (2) Severe dissection in the target vessel (NHLBI C muri F); (3) Angulation of a calcium arc of >=60 degree.

Design outcomes

Primary

MeasureTime frame
Success rate of clinical operation;

Secondary

MeasureTime frame
major cardiac event at 1 year;

Countries

China

Contacts

Public ContactLikun Ma

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

lkma119@163.com+86 18756967633

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026