Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter in the Treatment of In-stent Restenosis of Coronary Artery Lesion With Paclitaxel Release Coronary Balloon Catheter

NCT02891018 | Unknown Phase 3

• 1 other identifier: Branden-123456
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

In-stent Restenosis

Outcome Measures

Primary Outcomes (1)

• Late Lumen Loss

  at 9 months

Secondary Outcomes (6)

• Device Success Rate

  at 9 months

• Operation Success Rate

  at 9 months

• Target lesion in-segment rate after operation 9 months

  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

Study Arms (2)

paclitaxel controlled release balloon catheter

EXPERIMENTAL

Patients treated with paclitaxel controlled release balloon catheter

Device: paclitaxel controlled release balloon catheter Vasoguard TM

paclitaxel release coronary balloon catheter

EXPERIMENTAL

Patients treated with paclitaxel release coronary balloon catheter

Device: paclitaxel release coronary balloon catheter SeQuent Please

Interventions

paclitaxel controlled release balloon catheter Vasoguard TM DEVICE

paclitaxel controlled release balloon catheter

paclitaxel release coronary balloon catheter SeQuent Please DEVICE

paclitaxel release coronary 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; 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).

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 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.

Sponsors & Collaborators

• Shandong Branden Med.Device Co.,Ltd: lead
• Fudan University: collaborator

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: 2016-08

Locations

CN (1)