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

In-stent Restenosis Clinical Trial

Official title:

A Multicenter, Prospective and Randomized Controlled Clinical Study (VasoguardTM Trial II) That Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter (VasoguardTM) in the Treatment of In-stent Restenosis of Coronary Artery Lesion With Paclitaxel Release Coronary Balloon Catheter (SeQuent Please)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02891018
• Other study ID #: Branden-123456
• Status: Recruiting
• Phase: Phase 3
• First received: August 31, 2016
• Last updated: September 7, 2016
• Start date: December 2015

Study information

• Verified date: August 2016
• Source: Shandong Branden Med.Device Co.,Ltd
• Contact: Yuxia Yin
• Phone: 18596253015
• Email: yinyx[@]brandentech.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• In-stent Restenosis

Intervention

Device:
• paclitaxel controlled release balloon catheter Vasoguard TM

• paclitaxel release coronary balloon catheter SeQuent Please

Locations

Country	Name	City	State
China	Zhongshan Hospital Fudan University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Shandong Branden Med.Device Co.,Ltd	Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late Lumen Loss		at 9 months	No
Secondary	Device Success Rate		at 9 months	Yes
Secondary	Operation Success Rate		at 9 months	Yes
Secondary	Target lesion in-segment rate after operation 9 months		at 9 months	Yes
Secondary	Target lesion revascularization (TLR) and Target vessel revascularization (TVR) by clinical-driven		at 9 months	Yes
Secondary	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	Yes
Secondary	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	Yes