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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02891018
Recruitment Status : Unknown
Verified August 2016 by Shandong Branden Med.Device Co.,Ltd.
Recruitment status was:  Recruiting
First Posted : September 7, 2016
Last Update Posted : September 9, 2016
Sponsor:
Collaborator:
Fudan University
Information provided by (Responsible Party):
Shandong Branden Med.Device Co.,Ltd

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


Condition or disease Intervention/treatment Phase
In-stent Restenosis Device: paclitaxel controlled release balloon catheter Vasoguard TM Device: paclitaxel release coronary balloon catheter SeQuent Please Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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)
Study Start Date : December 2015
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: paclitaxel controlled release balloon catheter
Patients treated with paclitaxel controlled release balloon catheter
Device: paclitaxel controlled release balloon catheter Vasoguard TM
Experimental: paclitaxel release coronary balloon catheter
Patients treated with paclitaxel release coronary balloon catheter
Device: paclitaxel release coronary balloon catheter SeQuent Please



Primary Outcome Measures :
  1. Late Lumen Loss [ Time Frame: at 9 months ]

Secondary Outcome Measures :
  1. Device Success Rate [ Time Frame: at 9 months ]
  2. Operation Success Rate [ Time Frame: at 9 months ]
  3. Target lesion in-segment rate after operation 9 months [ Time Frame: at 9 months ]
  4. Target lesion revascularization (TLR) and Target vessel revascularization (TVR) by clinical-driven [ Time Frame: at 9 months ]
  5. Major adverse cardiovascular events (MACE) related with device, include cardiac death, myocardial infarction of target vessel and target lesion revascularization (TLR) by clinical-driven [ Time Frame: at 9 months ]
  6. 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) [ Time Frame: at 9 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891018


Contacts
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Contact: Yuxia Yin 18596253015 yinyx@brandentech.com

Locations
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China, Beijing
Zhongshan Hospital Fudan University Recruiting
Beijing, Beijing, China, 100032
Contact: Junbo Ge    13901977506      
Sponsors and Collaborators
Shandong Branden Med.Device Co.,Ltd
Fudan University
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Responsible Party: Shandong Branden Med.Device Co.,Ltd
ClinicalTrials.gov Identifier: NCT02891018    
Other Study ID Numbers: Branden-123456
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action