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Trial record 1 of 1 for:    NCT02944890
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Compare the Efficacy and Safety of RESTORE DEB and SeQuent® Please in Chinese Patient With Coronary In-stent Restenosis

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ClinicalTrials.gov Identifier: NCT02944890
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
R&G Pharma Studies Co.,Ltd.
Information provided by (Responsible Party):
ZhuHai Cardionovum Medical Device Co., Ltd.

Tracking Information
First Submitted Date  ICMJE October 24, 2016
First Posted Date  ICMJE October 26, 2016
Last Update Posted Date July 29, 2019
Study Start Date  ICMJE May 2016
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
In-segment late lumen loss of the target lesion [ Time Frame: 9 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
  • The success rate of intervention treatment: including device success, lesion success and clinical success [ Time Frame: 1-2 days ]
  • Occurrence rate of restenosis in the target lesions [ Time Frame: 9 months after the operation ]
  • Target lesion revascularization (TLR) rate [ Time Frame: 1, 6, 9, and 12 months after the operation ]
  • Target vessel revascularization (TVR) rate [ Time Frame: 1, 6, 9, and 12 months after the operation ]
  • Target lesion failure (TLF) rate [ Time Frame: 1, 6, 9, and 12 months after the operation ]
  • Occurrence rate of major adverse cardiovascular events [ Time Frame: 1, 6, 9, and 12 months after the operation ]
  • All adverse events and severe adverse events [ Time Frame: 1, 6, 9, and 12 months after the operation ]
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 Compare the Efficacy and Safety of RESTORE DEB and SeQuent® Please in Chinese Patient With Coronary In-stent Restenosis
Official Title  ICMJE A Multicenter, Randomized, Controlled Study to Compare the Efficacy and Safety of 2 Types of Drug Eluting Balloon Catheters (RESTORE DEB and SeQuent® Please) in Chinese Patient With Coronary In-stent Restenosis (ISR)
Brief Summary The purpose of this study is to evaluate the safety and efficacy of Paclitaxel drug eluting balloons (RESTORE DEB, 3μg/mm2 balloon surface area ) for success of intervention treatment and maintaining the vessels unobstructed in the treatment of coronary in-stent restenosis compared with a product of the same category (SeQuent® Please).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Coronary Restenosis
Intervention  ICMJE
  • Device: Drug Eluting Balloon Catheters(RESTORE DEB)
  • Device: Drug Eluting Balloon Catheters(SeQuent® Please)
Study Arms  ICMJE
  • Experimental: RESTORE DEB
    Conduct Drug Eluting Balloon Catheters(RESTORE DEB)
    Intervention: Device: Drug Eluting Balloon Catheters(RESTORE DEB)
  • Active Comparator: SeQuent® Please
    Conduct Drug Eluting Balloon Catheters(SeQuent® Please)
    Intervention: Device: Drug Eluting Balloon Catheters(SeQuent® Please)
Publications * Chen Y, Gao L, Qin Q, Chen S, Zhang J, Chen H, Wang L, Jin Z, Zheng Y, Zhang Z, Li H, Li X, Fu G, Chen L, Sun Z, Wang Y, Jin Q, Cao F, Guo J, Zhao Y, Guan C, Li W, Xu B; RESTORE ISR China Investigators. Comparison of 2 Different Drug-Coated Balloons in In-Stent Restenosis: The RESTORE ISR China Randomized Trial. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2368-2377. doi: 10.1016/j.jcin.2018.09.010.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2018)
242
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2016)
240
Actual Study Completion Date  ICMJE May 2019
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Related to the patients:

  1. Age ≥18 years old
  2. Patients agree to receive follow-ups in month-1, 6, 9 and 12, and receive angiography in month-9.
  3. Patients are able to understand the objectives of the study mentally and in language. Patients should indicate sufficient compliance to the study, and acknowledge all risks and benefits by signing the informed consent form.
  4. Patients with stable angina pectoris, or unstable angina pectoris, or old myocardial infarction, or proved asymptomatic regional myocardial ischemia
  5. Patients suitable to receive coronary revascularization of any type (including balloon angioplasty, stent implantation or coronary artery bypass grafting)

    Related to the diseases:

  6. Restenosis Mehran type I-III after stent implantation (including bare metal stents, stents with inert coating, and stents with active coating) for the first time
  7. Diameter of the stent with restenosis should be 2.5-4.0mm (included). Length of the stenosis lesion should be no more than 26mm, and diameter stenosis before operation should be ≥70%, or ≥50% with the evidence of ischemia.
  8. One subject is allowed to have 2 target lesions at most, and 2 Paclitaxel drug balloons for dilation.
  9. The distance between lesions which require intervention and the target lesions must be >10mm.

Exclusion Criteria:

Related to the patients:

  1. Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives.
  2. The patients are participating in any other clinical trials before reaching the primary endpoints.
  3. The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months.
  4. The patients had cerebral stroke within 6 months before being included, or have a history of peptic ulcer or gastrointestinal bleeding in the past 6 months, or the patients have a bleeding tendency according to the investigator.
  5. Patients with a history of leukopenia (white blood cell count <3×109/L for more than 3 days) or neutropenia (ANC<1000/mm3 for more than 3 days) or thrombocytopenia (platelet <100,000/mm3)
  6. Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel
  7. Patients with renal insufficiency (eGFR<30mL/min)
  8. Patients who are known to be allergic to Paclitaxel
  9. Patients who had myocardial infarction within 1 week before being included
  10. Patients who had heart transplantation
  11. Patients with severe congestive heart failure or NYHA grade IV heart failure
  12. Patients with severe valvular heart disease
  13. Patients who are unsuitable for the study according to the investigator due to other reasons

    Related to the diseases:

  14. Patients with evidence of extensive thrombosis in the target vessel before intervention
  15. Patients with total occlusion indicating TIMI 0 blood flow at the target lesion (Mehran type IV stenosis)
  16. Patients with multiple lesions (≥3) requiring percutaneous coronary intervention treatment in the same artery
  17. Patients with lesions requiring intervention treatment in 3 vessels
  18. The diameter of the branch lesions in the target lesion ≥2.5mm
  19. Patients already treated with CABG after in-stent restenosis
  20. LM lesions and Ostial lesion within 5mm to the root aorta
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT02944890
Other Study ID Numbers  ICMJE RG01W-1101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ZhuHai Cardionovum Medical Device Co., Ltd.
Study Sponsor  ICMJE ZhuHai Cardionovum Medical Device Co., Ltd.
Collaborators  ICMJE R&G Pharma Studies Co.,Ltd.
Investigators  ICMJE
Principal Investigator: Yundai Chen, PhD Chinese PLA General Hospital
PRS Account ZhuHai Cardionovum Medical Device Co., Ltd.
Verification Date July 2017

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