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

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Device: OCT-guided paclitaxel drug-coated balloon angioplasty; Device: Angiography-guided paclitaxel drug-coated balloon angioplasty

• Registration Number: NCT04276389
• Lead Sponsor: Beijing Anzhen Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-18
• Last Update Submitted: 2020-02-18
• Study First Posted: 2020-02-19
• Last Update Posted: 2020-02-19
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OCT-guided arm	OCT-guided paclitaxel drug-coated balloon angioplasty	-
Angiography-guided arm	Angiography-guided paclitaxel drug-coated balloon angioplasty	-

Primary Outcome Measures

Name	Time	Method
Late lumen loss	9 months	Evaluated by QCA

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, China