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)

NCT02891005 | Unknown Phase 3

• 1 other identifier: Branden-123
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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)

Conditions

Small Vessel Lesion

Outcome Measures

Primary Outcomes (1)

• Late lumen loss

  at 9 months

Secondary Outcomes (4)

• Incidence of Device Success

  at 9 months

• Incidence of Operation Success

  at 9 months

• Incidence of the target lesion in-segment restenosis (%) at 9mm

  at 9 months

• Clinical-driven target lesion revascularization (TLR) and target vessel revascularization (TVR)

  at 9 months

Study Arms (2)

paclitaxel controlled release balloon catheter

EXPERIMENTAL

Patients treated with paclitaxel controlled release balloon catheter

Device: paclitaxel controlled release balloon catheter (VasoguardTM)

common balloon catheter

EXPERIMENTAL

Patients treated with common balloon catheter

Device: common balloon catheter (Maverick2)

Interventions

paclitaxel controlled release balloon catheter (VasoguardTM) DEVICE

paclitaxel controlled release balloon catheter implantation for small vessel lesion

paclitaxel controlled release balloon catheter

common balloon catheter (Maverick2) DEVICE

common balloon catheter implantation for small vessel lesion

common balloon catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Branden Med.Device Co.,Ltd: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Beijing, Beijing Municipality, 100032, China

RECRUITING

Central Study Contacts

Yuxia Yin

CONTACT

18596253015; yinyx@brandentech.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 7, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

CN (1)