DCB Treatment in CTO Guided by IVUS

Last updated: September 16, 2023
Sponsor: Xuzhou Central Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Heart Disease

Chest Pain

Treatment

PCI

Clinical Study ID

NCT06050096
001
  • Ages > 18
  • All Genders

Study Summary

The percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) coronary artery disease is difficult, the success rate is low, and the incidence of re-occlusion and restenosis is high. With the wide application of imaging technology represented by intravascular ultrasound (IVUS), the success rate of CTO PCI has been significantly improved. Drug-coated balloons (DCB), as a treatment without metal implantation, has lower lumen loss and no significant increase in the rate of revascularization. Through IVUS measurement of vascular lumen after CTO opening, appropriate instruments can be selected for adequate dilation, and appropriate treatment methods can be selected according to different lumen structures. Therefore, the purpose of this study was to evaluate the clinical effect of IVUS-guided DCB therapy on CTO lesions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Over the age of 18, male or female;
  2. Patients who meet the diagnostic criteria for coronary heart disease, have clinicalsymptoms and seek interventional treatment;
  3. Coronary angiography confirmed that the blood vessels met the diagnostic criteria ofCTO;
  4. Sign informed consent and be willing to undergo follow-up for at least 12 months.

Exclusion

Exclusion Criteria:

  1. Patients with severe contrast allergy who cannot tolerate coronary angiography;
  2. Patients known allergy to drug balloon coating;
  3. Patients who is pregnant or breastfeeding;
  4. Bleeding or other diseases, such as digestive tract ulcers, blood system diseases,etc., limit the use of platelet aggregation inhibitors and anticoagulation therapy;
  5. Patients with cardiac shock;
  6. Patients with a life expectancy of less than 1 year;
  7. Other situations deemed unsuitable for inclusion by the researcher.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: PCI
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
October 01, 2025

Connect with a study center

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu 221000
    China

    Active - Recruiting

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