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

Capital Medical University

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Device: OCT-guided paclitaxel drug-coated balloon angioplasty; Device: Angiography-guided paclitaxel drug-coated balloon angioplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04276389

2018015

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups, including a placebo group

OCT-guided arm

Active Comparator group

Treatment:

Device: OCT-guided paclitaxel drug-coated balloon angioplasty

Angiography-guided arm

Placebo Comparator group

Treatment:

Device: Angiography-guided paclitaxel drug-coated balloon angioplasty