OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery

OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery After Lesion Preparation With Scoring Balloon - A Prospective Multicenter Cohort Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04276389

Enrollment

Registered

2020-02-19

Start date

2017-08-01

Completion date

2020-08-31

Last updated

2020-02-19

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

Conditions

Coronary Artery Disease

Brief summary

OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter cohort study aims to assess the efficacy and safety of OCT- versus angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery after lesion preparation with scoring balloon.

Interventions

DEVICEOCT-guided paclitaxel drug-coated balloon angioplasty

OCT-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery

DEVICEAngiography-guided paclitaxel drug-coated balloon angioplasty

Angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. 18 to 85 years old 2. Patients have ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of a stenosis of at least 50% in a native coronary artery, including stable angina, unstable angina, or silent ischemia. 3. Reference vessel diameter \>2.5 mm, and \<4.0 mm. 4. Lesion length of \<22 mm 5. Written informed consent

Exclusion criteria

1. Myocardial infarction within 4 weeks, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction 2. Cardiogenic shock (systolic arterial pressure \<90mmHg), congestive heart failure (NYHA or Killip≥3) 3. Chronic kidney disease (eGFR \<30 ml/min) 4. Lesion length \>22 mm, or vessel diameters of \<2.5 mm or \>4.0 mm 5. Stents covering a major side branch (\>2 mm) 6. Left main lesion 7. Graft lesion 8. Aortic-coronary ostial lesion 9. In-stent restenotic lesion 10. Chronic total occlusion 11. Severe calcified lesions. 12. Visible angiographic thrombus 13. Severe comorbidities: eg. malignancy (life expectancy \<2 years)

Design outcomes

Primary

Measure	Time frame	Description
Late lumen loss	9 months	Evaluated by QCA

Secondary

Measure	Time frame	Description
Rate of binary restenosis	9 months	Evaluated by QCA
Target lesion failure	9 months	Including death, target vessel myocardial infarction, or target lesion revascularization

Countries

China

Contacts

Primary ContactShao-Ping Nie, MD, PhD

spnie@ccmu.edu.cn86-10-84005256

Backup ContactYaping Zeng, MD

zengyaping2@163.com86-10-84005255

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026