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| Name | Class |
|---|---|
| Fudan University | OTHER |
Study purpose The safety and efficacy of paclitaxel controlled release balloon catheter Vasoguard TM in treatment of in-stent restenosis.
Study group Experimental group: paclitaxel controlled release balloon catheter Vasoguard TM Control group: paclitaxel release coronary balloon catheter SeQuent Please
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paclitaxel controlled release balloon catheter | Experimental | Patients treated with paclitaxel controlled release balloon catheter |
|
| paclitaxel release coronary balloon catheter | Experimental | Patients treated with paclitaxel release coronary balloon catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel controlled release balloon catheter Vasoguard TM | Device |
| ||
| paclitaxel release coronary balloon catheter SeQuent Please |
| Measure | Description | Time Frame |
|---|---|---|
| Late Lumen Loss | at 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success Rate | at 9 months | |
| Operation Success Rate | at 9 months | |
| Target lesion in-segment rate after operation 9 months |
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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; Subject occurred restenosis after vessel lesion in situ receiving the first stent operation; In-stent restenosis type Mehran I, II, III, IV, reference vessel diameter of 1.5-4.0 mm, length of 40 mm or less; Target lesion stenosis must be equal or greater than 70% or 50% and with evidence of ischemia; Single or two coronary small vessel lesions in situ; Other lesion which need interventional treatment must be away from target lesion at least 10 mm; 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 anticoagulation 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 who had 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: Three or more coronary artery vessel lesion; Target vessel has extensive thrombosis evidence; Restenosis of vein graft after bypass surgery; Left main coronary artery and ostial lesion within 2mm; 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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| Device |
|
| at 9 months |
| Target lesion revascularization (TLR) and Target vessel revascularization (TVR) by clinical-driven | at 9 months |
| Major adverse cardiovascular events (MACE) related with device, include cardiac death, myocardial infarction of target vessel and target lesion revascularization (TLR) by clinical-driven | at 9 months |
| Thrombotic events incidence (ARC definition include deterministic thrombosis, possible thrombosis and not eliminating thrombosis; point-in-time include acute within 24h, subacute between 2 and 30 d and later period over 30 d) | at 9 months |