- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04276389
OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery
February 18, 2020 updated by: Shao-Ping Nie, Beijing Anzhen Hospital
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
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yaping Zeng, MD
- Phone Number: 86-10-84005255
- Email: zengyaping2@163.com
Study Locations
-
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: OCT-guided arm
|
OCT-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery
|
Placebo Comparator: Angiography-guided arm
|
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
Time Frame: 9 months
|
Evaluated by QCA
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of binary restenosis
Time Frame: 9 months
|
Evaluated by QCA
|
9 months
|
Target lesion failure
Time Frame: 9 months
|
Including death, target vessel myocardial infarction, or target lesion revascularization
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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