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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

Tracking Information
First Submitted Date  ICMJE August 31, 2016
First Posted Date  ICMJE September 7, 2016
Last Update Posted Date September 9, 2016
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2016)
Late Lumen Loss [ Time Frame: at 9 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2016)
  • Device Success Rate [ Time Frame: at 9 months ]
  • Operation Success Rate [ Time Frame: at 9 months ]
  • Target lesion in-segment rate after operation 9 months [ Time Frame: at 9 months ]
  • Target lesion revascularization (TLR) and Target vessel revascularization (TVR) by clinical-driven [ Time Frame: 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 [ Time Frame: at 9 months ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE In-stent Restenosis
Intervention  ICMJE
  • Device: paclitaxel controlled release balloon catheter Vasoguard TM
  • Device: paclitaxel release coronary balloon catheter SeQuent Please
Study Arms  ICMJE
  • Experimental: paclitaxel controlled release balloon catheter
    Patients treated with paclitaxel controlled release balloon catheter
    Intervention: Device: paclitaxel controlled release balloon catheter Vasoguard TM
  • Experimental: paclitaxel release coronary balloon catheter
    Patients treated with paclitaxel release coronary balloon catheter
    Intervention: Device: paclitaxel release coronary balloon catheter SeQuent Please
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 31, 2016)
260
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02891018
Other Study ID Numbers  ICMJE Branden-123456
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shandong Branden Med.Device Co.,Ltd
Study Sponsor  ICMJE Shandong Branden Med.Device Co.,Ltd
Collaborators  ICMJE Fudan University
Investigators  ICMJE Not Provided
PRS Account Shandong Branden Med.Device Co.,Ltd
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP