search
Back to results

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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
OCT-guided paclitaxel drug-coated balloon angioplasty
Angiography-guided paclitaxel drug-coated balloon angioplasty
Sponsored by
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Beijing Anzhen Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

OCT-guided arm

Angiography-guided arm

Arm Description

Outcomes

Primary Outcome Measures

Late lumen loss
Evaluated by QCA

Secondary Outcome Measures

Rate of binary restenosis
Evaluated by QCA
Target lesion failure
Including death, target vessel myocardial infarction, or target lesion revascularization

Full Information

First Posted
February 18, 2020
Last Updated
February 18, 2020
Sponsor
Beijing Anzhen Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04276389
Brief Title
OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OCT-guided arm
Arm Type
Active Comparator
Arm Title
Angiography-guided arm
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
OCT-guided paclitaxel drug-coated balloon angioplasty
Intervention Description
OCT-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery
Intervention Type
Device
Intervention Name(s)
Angiography-guided paclitaxel drug-coated balloon angioplasty
Intervention Description
Angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery
Primary Outcome Measure Information:
Title
Late lumen loss
Description
Evaluated by QCA
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Rate of binary restenosis
Description
Evaluated by QCA
Time Frame
9 months
Title
Target lesion failure
Description
Including death, target vessel myocardial infarction, or target lesion revascularization
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to 85 years old 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. Reference vessel diameter >2.5 mm, and <4.0 mm. Lesion length of <22 mm Written informed consent Exclusion Criteria: Myocardial infarction within 4 weeks, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction Cardiogenic shock (systolic arterial pressure <90mmHg), congestive heart failure (NYHA or Killip≥3) Chronic kidney disease (eGFR <30 ml/min) Lesion length >22 mm, or vessel diameters of <2.5 mm or >4.0 mm Stents covering a major side branch (>2 mm) Left main lesion Graft lesion Aortic-coronary ostial lesion In-stent restenotic lesion Chronic total occlusion Severe calcified lesions. Visible angiographic thrombus Severe comorbidities: eg. malignancy (life expectancy <2 years)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shao-Ping Nie, MD, PhD
Phone
86-10-84005256
Email
spnie@ccmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yaping Zeng, MD
Phone
86-10-84005255
Email
zengyaping2@163.com
Facility Information:
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaping Zeng, MD
Phone
86-10-84005255
Email
zengyaping2@163.com
First Name & Middle Initial & Last Name & Degree
Xiao Wang, MD
Phone
86-10-84005255
Email
spaceeye123@126.com
First Name & Middle Initial & Last Name & Degree
Shao-Ping Nie, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs