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This study was to investigate the effect and safety of drug eluting balloon combined for treatment of unstable angina.
Patients with unstable angina were randomized to drug eluting stent only or drug eluting balloon group. Angiographic follow-up was performed after 12 months. The primary endpoints were late lumen loss (LLL) and the secondary endpoints were target lesion revascularization (TLR),and the major adverse cardiovascular events (MACE) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| drug eluting balloon group | Experimental | patients with unstable angina were randomised to drug eluting balloon group for percutaneous transluminal coronary angioplasty with a strategy of cutting balloon(Flextome Cutting Balloon, Boston Scientific Corporation, US) pre-dilation first and then drug eluting balloon(Sequent please; B. Braun, Melsungen, Germany) . |
|
| drug eluting stent group | Experimental | patients with unstable angina were randomised to this group for drug eluting stent (YINYI® Polymer-free Drug-coated (Paclitaxel) Coronary Stent System, Liaoning Biomedical Materials R&D Center Co., Ltd. China) implantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug eluting balloon; cutting balloon | Device | Patients eligible for inclusion criteria were randomised to study group for percutaneous transluminal coronary angioplasty with a strategy of cutting balloon pre-dilation first and then drug eluting balloon. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Target Lumen assessed by optical coherence tomography | A coronary de novo lesion in patient after intervened was measured with optical coherence tomography .To measure the changes in target lumen at 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of MACE | MACE include composite of death, myocardial infarction, or target-vessel revascularization | Incidence rate of MACE from baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LI BO, MD | Contact | +8601055499309 | 22401919@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| CHEN YUN DAI, MD | The General Hospital of PLA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The General Hospital of PLA | Recruiting | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27846629 | Derived | Li B, Ding Y, Tian F, Chen W, Han T, Chen Y. Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial. Cardiology. 2017;136(4):252-257. doi: 10.1159/000452125. Epub 2016 Nov 16. |
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| ID | Term |
|---|---|
| D000789 | Angina, Unstable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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|
| drug eluting stent | Device | with a strategy of drug-eluting stent implantation alone for de novo coronary artery lesions. |
|
|
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |