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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)

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: NCT02891005
Recruitment Status : Unknown
Verified September 2016 by Shandong Branden Med.Device Co.,Ltd.
Recruitment status was:  Recruiting
First Posted : September 7, 2016
Last Update Posted : September 9, 2016
Sponsor:
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 VasoguardTM in treatment of small vessel lesion.

Study Group Experimental group: paclitaxel controlled release balloon catheter (VasoguardTM) Control group: common balloon catheter (Maverick2)


Condition or disease Intervention/treatment Phase
Small Vessel Lesion Device: paclitaxel controlled release balloon catheter (VasoguardTM) Device: common balloon catheter (Maverick2) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 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 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)
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 (VasoguardTM)
paclitaxel controlled release balloon catheter implantation for small vessel lesion

Experimental: common balloon catheter
Patients treated with common balloon catheter
Device: common balloon catheter (Maverick2)
common balloon catheter implantation for small vessel lesion




Primary Outcome Measures :
  1. Late lumen loss [ Time Frame: at 9 months ]

Secondary Outcome Measures :
  1. Incidence of Device Success [ Time Frame: at 9 months ]
  2. Incidence of Operation Success [ Time Frame: at 9 months ]
  3. Incidence of the target lesion in-segment restenosis (%) at 9mm [ Time Frame: at 9 months ]
  4. Clinical-driven target lesion revascularization (TLR) and target vessel revascularization (TVR) [ Time Frame: at 9 months ]


Information from the National Library of Medicine

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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; 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.


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): NCT02891005


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
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Responsible Party: Shandong Branden Med.Device Co.,Ltd
ClinicalTrials.gov Identifier: NCT02891005    
Other Study ID Numbers: Branden-123
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action