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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04276389
• Other study ID #: 2018015
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: August 31, 2020

Study information

• Verified date: February 2020
• Source: Beijing Anzhen Hospital
• Contact: Shao-Ping Nie, MD, PhD
• Phone: 86-10-84005256
• Email: spnie[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• OCT-guided paclitaxel drug-coated balloon angioplasty
OCT-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery
• Angiography-guided paclitaxel drug-coated balloon angioplasty
Angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late lumen loss	Evaluated by QCA	9 months
Secondary	Rate of binary restenosis	Evaluated by QCA	9 months
Secondary	Target lesion failure	Including death, target vessel myocardial infarction, or target lesion revascularization	9 months