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OCT evaluation of restenotic plaque characteristics and clinical prognosis in stable coronary heart disease patients after treatment with drug-eluting balloon and drug-eluting stent

OCT evaluation of restenotic plaque characteristics and clinical prognosis in stable coronary heart disease patients after treatment with drug-eluting balloon and drug-eluting stent

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051323
Enrollment
Unknown
Registered
2021-09-20
Start date
2021-09-30
Completion date
Unknown
Last updated
2022-06-20

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

Conditions

coronary heart disease

Interventions

DCB group:DCB
DES group:DES

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged >= 18 years old; 2.Meet the diagnostic criteria for stable coronary heart disease; 3.All patients underwent coronary angiography and at least one major coronary artery had a stenosis of more than 70%, with PCI indications; 4.The same coronary vessel or its branches cannot be implanted with any stent at the same time; 5.Able to sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients who are clearly diagnosed as acute coronary syndrome; 2.Coronary angiography results show that the target coronary lesions include patients with spontaneous dissection, severe tortuosity, calcification and chronic occlusion; 3.Congenital heart disease; 4.Heart insufficiency caused by hyperdynamic heart disease such as hyperthyroidism and anemia; 5.Pulmonary heart disease; 6.Hypertrophic obstructive cardiomyopathy; 7.Severe hypotension (SBP<90mmHg or DBP<60mmHg when enrolled); 8.Previous postural hypotension; 9.Hepatic insufficiency (defined as ALT or total bilirubin greater than 3 times the upper limit of normal range); 10.Renal insufficiency (defined as blood creatinine greater than 1.5 times the upper limit of normal range); 11.Glaucoma; 12.Active peptic ulcer and skin ulcer; 13.Patients who are allergic to nitrates; 14.Patients who are allergic to niacin; 15.Pregnant and lactating women and women of childbearing age who cannot strictly use contraception during treatment; 16.Patients who have participated in other clinical research in the past 3 months; 17.Patients who do not have legal capacity or have limited legal capacity; 18.Any situation that the investigator considers possible candidates inappropriate to participate in the clinical study.

Design outcomes

Primary

MeasureTime frame
Restenosis plaque characteristics and clinical prognosis;

Secondary

MeasureTime frame
Success rate of operation;Target lesion revascularization;Failure of target lesion;Acute vascular occlusion;Target thrombus;All-Cause Mortality;Cardiac mortality rate;Major adverse cardiovascular eventsmajor adverse cardiovascular events;

Countries

China

Contacts

Public ContactZheng Yingying

The First Affiliated Hospital of Zhengzhou University

zhengying527@163.com+86 13253503223

Outcome results

None listed

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