Status:
UNKNOWN
Efficacy and Safety of Paclitaxel-eluting Balloon for Treatment of Lesions in Native Small Coronary Arteries
Lead Sponsor:
Gachon University Gil Medical Center
Collaborating Sponsors:
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Inje University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.
Detailed Description
Drug-eluting balloon (DEB) have emerged as a potential alternative to overcome the limitations of drug-eluting stents such as restenosis or stent thrombosis. DEB angioplasty is proven to be effective...
Eligibility Criteria
Inclusion
- Age ≥ 19 years
- Patients who are appropriate for percutaneous coronary intervention using drug-eluting balloon in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, lesion length \< 25 mm)
- Informed consent
Exclusion
- Chronic total obstruction lesion
- Severe calcified lesion
- Left main coronary lesion
- Lesion having intravascular thrombus
- Shock status from any cause including cardiogenic shock
- Left ventricular ejection fraction \< 30%
- Need for coronary artery bypass surgery
- Allergic reaction for paclitaxel
- Severe allergic for contrast agent (Visipaque) or statin
- Pregnancy, breastfeeding or Expectation for pregnancy in women of childbearing age
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT01903902
Start Date
June 1 2013
End Date
June 1 2015
Last Update
July 19 2013
Active Locations (1)
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1
Gachon University Gil Medical Center
Incheon, South Korea, 405-760