OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery
NCT ID: NCT04276389
Last Updated: 2020-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2017-08-01
2020-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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OCT-guided arm
OCT-guided paclitaxel drug-coated balloon angioplasty
OCT-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery
Angiography-guided arm
Angiography-guided paclitaxel drug-coated balloon angioplasty
Angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery
Interventions
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OCT-guided paclitaxel drug-coated balloon angioplasty
OCT-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery
Angiography-guided paclitaxel drug-coated balloon angioplasty
Angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
85 Years
ALL
No
Sponsors
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Beijing Anzhen Hospital
OTHER
Responsible Party
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Shao-Ping Nie
Professor of Medicine, Director, Emergency & Critical Care Center
Locations
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Beijing Anzhen Hospital, Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018015
Identifier Type: -
Identifier Source: org_study_id
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