A Phase 3 interventional study of paclitaxel controlled release balloon catheter (VasoguardTM) and common balloon catheter (Maverick2) in Small Vessel Lesion, sponsored by Shandong Branden Med.Device Co.,Ltd. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-09-09.
Sponsored by Shandong Branden Med.Device Co.,Ltd · Phase 3, Interventional, and Treatment
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)
1,117 studies on the registry are indexed under Constriction, Pathologic; 231 are open to participants now.
This study's planned enrollment of 230 is above the median of 80 across 672 interventional studies indexed under Constriction, Pathologic.
Browse Constriction, Pathologic studies →Shandong Branden Med.Device Co.,Ltd is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
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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.
Patients treated with paclitaxel controlled release balloon catheter
Device: paclitaxel controlled release balloon catheter (VasoguardTM)
Patients treated with common balloon catheter
Device: common balloon catheter (Maverick2)
paclitaxel controlled release balloon catheter implantation for small vessel lesion
common balloon catheter implantation for small vessel lesion
Late lumen loss
Time frame: at 9 months
Incidence of Device Success
Time frame: at 9 months
Incidence of Operation Success
Time frame: at 9 months
Incidence of the target lesion in-segment restenosis (%) at 9mm
Time frame: at 9 months
Clinical-driven target lesion revascularization (TLR) and target vessel revascularization (TVR)
Time frame: at 9 months
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Shandong Branden Med.Device Co.,Ltd