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Evaluation of the safety and efficacy of an increased number of models after the market for coronary stents

Evaluation of the safety and efficacy of an increased number of models after the market for coronary stents

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016037
Enrollment
Unknown
Registered
2018-05-08
Start date
2018-08-01
Completion date
Unknown
Last updated
2018-05-14

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

Conditions

Primary coronary artery stenosis causes symptomatic ischemic heart disease

Interventions

Case series:Implant stent

Sponsors

Inner Mongolia Autonomous Region People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients aged 18-80 years; (2) According to the guidelines for patients with symptomatic coronary artery disease treated with DES (first time); (3) There are 1 or more coronary artery lesions with diameter stenosis = 50%, among which 1-2 are suitable for implantation of 2.5*38, 2.75*38, 3.0*38, 3.5*38, or 4.0*38 stents; (4) Patient who willing to participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients who are expected to implant more than 3 stents in total; (2) Women who are pregnant or breastfeeding; (3) Patients who are not expected to adapt to antiplatelet and/or anticoagulant therapy; (4) This product is not suitable for patients who are allergic to rapamycin or 316L stainless steel, polyglycolide lactide polymer; (5) Patients whose lesions are thought to hinder the complete expansion of the angioplasty balloon; (6) Patients who have undergone transplant surgery; (7) The patient was also involved in other devices or drugs or other studies and had not yet reached the end of the study; (8) Patients undergoing elective clopidogrel surgery must be discontinued during normal planned clopidogrel use; (9) The researchers believe that patients are not suitable for stenting and can not complete follow-up, such as patients with advanced malignant tumors, severe liver and kidney disease, stroke patients, severe infections and severe hematological diseases.

Design outcomes

Primary

MeasureTime frame
Target lesion failure rate;

Secondary

MeasureTime frame
Instrument success rate;Surgery success rate;Loss of late lumen within target segment;Percentage of narrow diameter;

Countries

China

Contacts

Public ContactZhiyong Wang

Inner Mongolia Autonomous Region People's Hospital

luth@brandentech.com+86 13884126661

Outcome results

None listed

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