OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Aug 2017
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 18, 2020
CompletedFirst Posted
Study publicly available on registry
February 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedFebruary 19, 2020
February 1, 2020
3.1 years
February 18, 2020
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Late lumen loss
Evaluated by QCA
9 months
Secondary Outcomes (2)
Rate of binary restenosis
9 months
Target lesion failure
9 months
Study Arms (2)
OCT-guided arm
ACTIVE COMPARATORAngiography-guided arm
PLACEBO COMPARATORInterventions
OCT-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery
Angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Anzhen Hospital, Capital Medical University
Beijing, 100029, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine, Director, Emergency & Critical Care Center
Study Record Dates
First Submitted
February 18, 2020
First Posted
February 19, 2020
Study Start
August 1, 2017
Primary Completion
August 31, 2020
Study Completion
August 31, 2020
Last Updated
February 19, 2020
Record last verified: 2020-02