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Study Purpose The safety and efficacy of paclitaxel controlled release balloon catheter VasoguardTM in treatment of small vessel lesion.
Study Group Experimental group: paclitaxel controlled release balloon catheter (VasoguardTM) Control group: common balloon catheter (Maverick2)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paclitaxel controlled release balloon catheter | Experimental | Patients treated with paclitaxel controlled release balloon catheter |
|
| common balloon catheter | Experimental | Patients treated with common balloon catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel controlled release balloon catheter (VasoguardTM) | Device | paclitaxel controlled release balloon catheter implantation for small vessel lesion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late lumen loss | at 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Device Success | at 9 months | |
| Incidence of Operation Success | at 9 months | |
| Incidence of the target lesion in-segment restenosis (%) at 9mm |
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Inclusion Criteria:
Subject need 18 to 80 years of aged male or non-pregnant women; Subject has stable anina pectoris, or unstable anina pectoris, or old myocardial infarction patients, or ischemia with evidence but without symptom; Subject has a life expectancy of more than 2 years; Lesion vessel reference diameter is less than or equal to 2.5mm, target lesion length is less than or equal to 40mm; Target lesion stenosis is equal or greater than 70% or 50% and with ischemia; Single or two coronary small vessel lesions in situ; Subject can understand the trail purpose, sign informed consent voluntarily, agree to accept clinical telephone follow-up and angiographic follow-up at 9 months; Target lesion can be pre-expanded successfully (Guide wire can get through lesion, balloon pre-expand the remnant stenosis of vessel lumen is less or equal to 50%, without current limiting interlayer and thrombosis).
Exclusion Criteria:
Patient that in the opinion of the investigator is not appropriate for this trail; Pregnancy and lactation female patients; Patient has a life expectancy of less than 2 years; Severe congestive heart failure or NYHA IV heart failure; Patient who have bleeding constitution, cannot use antithrombotic and antiplatelet drugs; Patient that happened acute myocardial infarction within a week; Patient who happened stroke within six months; Patient who with severe renal failure (GFR≤30ml/Min); Patient has received heart transplantation; Patient who cannot tolerate aspirin and / or P2Y12 receptor inhibitor drugs; Patient who has allergy to paclitaxel, PLGA or contrast agent; Peptic ulcer or gastrointestinal bleeding within the prior 6 months; Patients who are participating in another drug or device clinical trail, which have not completed the primary endpoint follow- up period.
Angiographic relevant: Merge three or more coronary small vessel lesions; Target vessel with extensive thrombosis evidence; Restenosis of vein graft after bypass surgery; Target lesion proximal exist seriously distorted or severe calcified lesion.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuxia Yin | Contact | 18596253015 | yinyx@brandentech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Recruiting | Beijing | Beijing Municipality | 100032 | China |
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| common balloon catheter (Maverick2) | Device | common balloon catheter implantation for small vessel lesion |
|
| at 9 months |
| Clinical-driven target lesion revascularization (TLR) and target vessel revascularization (TVR) | at 9 months |