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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: OCT-guided paclitaxel drug-coated balloon angioplasty; Device: Angiography-guided paclitaxel drug-coated balloon angioplasty

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100029
    • Recruiting
    • Beijing Anzhen Hospital, Capital Medical University
    • Contact: Yaping Zeng, MD; Phone Number: 86-10-84005255; Email: zengyaping2@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OCT-guided arm	Device: OCT-guided paclitaxel drug-coated balloon angioplasty; OCT-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery
Placebo Comparator: Angiography-guided arm	Device: Angiography-guided paclitaxel drug-coated balloon angioplasty; Angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late lumen loss	Evaluated by QCA	9 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): August 31, 2020

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: 2018015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No