NCT02891005UnknownPhase 3
A Multicenter, Prospective and Randomized Controlled Clinical Study (VasoguardTM Trial I) That Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter (VasoguardTM) in the Treatment of Small Coronary Vessel Stenosis With a Common Coronary Balloon Catheter (Maverick2)
Shandong Branden Med.Device Co.,Ltd1 site in 1 country230 target enrollmentStarted: December 1, 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 230
- Locations
- 1
- Primary Endpoint
- Late lumen loss
Study Overview
Brief Summary
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
paclitaxel controlled release balloon catheter
Experimental
Patients treated with paclitaxel controlled release balloon catheter
Intervention: paclitaxel controlled release balloon catheter (VasoguardTM) (Device)
common balloon catheter
Experimental
Patients treated with common balloon catheter
Intervention: common balloon catheter (Maverick2) (Device)
Outcomes
Primary Outcomes
Late lumen loss
Time Frame: at 9 months
Secondary Outcomes
- Incidence of Operation Success(at 9 months)
- Incidence of the target lesion in-segment restenosis (%) at 9mm(at 9 months)
- Incidence of Device Success(at 9 months)
- Clinical-driven target lesion revascularization (TLR) and target vessel revascularization (TVR)(at 9 months)
Investigators
Study Sites (1)
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