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| Name | Class |
|---|---|
| Shanghai Tongji Hospital, Tongji University School of Medicine | OTHER |
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The purpose of the trial is to determine whether DCB made by Acotec Scientific is not inferior to RESTORE DEB made by CARDIONOVUM GmbH in treatment of small vessel coronary disease.
This is a prospective, multi-center, randomized-controlled clinical trial to verify the efficacy and safety of DCB made by Acotec Scientific versus RESTORE DEB in treatment of small vessel coronary disease. And the primary endpoint is angiographic restenosis at 9 months post-procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test DCB group | Experimental | use the DCB made by Acotec Scientific |
|
| RESTORE DCB group | Active Comparator | use the DCB made by CARDIONOVUM GmbH |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| test DCB | Device | use paclitaxel coated coronary balloon catheters to treat SVD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic percent diameter stenosis | (1-Segmental minimum lumen diameter [MLD]/ segmental reference vessel diameter [RVD]) ×100% | at 9 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Acute success | Including instrument success rate, lesion success rate and surgical success rate | in the procedure |
| Rate of target lesion failure | A composite of cardiac death, target-vessel related myocardial infarction, and ischemia-driven target lesion revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuebo Liu, MD | Contact | 021-56051080 | lxb70@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xuebo Liu, MD | Shanghai Tongji Hospital, Tongji University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tongji Hospital, Tongji University School of Medicine | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| RESTORE DCB |
| Device |
use paclitaxel coated coronary balloon catheters(RESTORE DCB) with NMPA approval indication for treating SVD |
|
| within 12 months post-procedure |
| Diameter stenosis in-device | (1-the minimum cavity diameter of the device [MLD] / the reference vessel diameter of the device [RVD]) ×100% | at 9 months post-procedure |
| Late lumen loss | Loss of late lumen in the segment and device | at 9 months post-procedure |