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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 25, 2018
Sponsor:
Collaborator:
R&G Pharma Studies Co.,Ltd.
Information provided by (Responsible Party):
ZhuHai Cardionovum Medical Device Co., Ltd.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Coronary Restenosis Device: Drug Eluting Balloon Catheters(RESTORE DEB） Device: Drug Eluting Balloon Catheters(SeQuent® Please） Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : May 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: RESTORE DEB
Conduct Drug Eluting Balloon Catheters(RESTORE DEB）
 Device: Drug Eluting Balloon Catheters(RESTORE DEB）
Active Comparator: SeQuent® Please
Conduct Drug Eluting Balloon Catheters(SeQuent® Please）
 Device: Drug Eluting Balloon Catheters(SeQuent® Please）


Outcome Measures
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Primary Outcome Measures :
  1. In-segment late lumen loss of the target lesion [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. The success rate of intervention treatment: including device success, lesion success and clinical success [ Time Frame: 1-2 days ]
  2. Occurrence rate of restenosis in the target lesions [ Time Frame: 9 months after the operation ]
  3. Target lesion revascularization (TLR) rate [ Time Frame: 1, 6, 9, and 12 months after the operation ]
  4. Target vessel revascularization (TVR) rate [ Time Frame: 1, 6, 9, and 12 months after the operation ]
  5. Target lesion failure (TLF) rate [ Time Frame: 1, 6, 9, and 12 months after the operation ]
  6. Occurrence rate of major adverse cardiovascular events [ Time Frame: 1, 6, 9, and 12 months after the operation ]
  7. All adverse events and severe adverse events [ Time Frame: 1, 6, 9, and 12 months after the operation ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02944890


Locations
China, Beijing
Beijing Chaoyang Hospital
Beijing, Beijing, China, 100020
Beijing Anzhen Hospital,Capital Medical University
Beijing, Beijing, China, 100029
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing, China, 100050
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
China, Gansu
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
China, Hebei
Cangzhou Central Hospital
Cangzhou, Hebei, China, 061001
China, Heilongjiang
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China, 163000
China, Jiangsu
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
China, Jilin
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
The Second Hospital of Jilin University
Changchun, Jilin, China, 130041
China, Shaanxi
Tangdu Hospital
Xi'an, Shaanxi, China, 710038
China, Tianjin
Tianjin Chest Hospital
Tianjin, Tianjin, China, 30051
China, Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Sir Run Run Shaw Hospital School of medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310016
Sponsors and Collaborators
ZhuHai Cardionovum Medical Device Co., Ltd.
R&G Pharma Studies Co.,Ltd.
Investigators
Principal Investigator: Yundai Chen, PhD Chinese PLA General Hospital
More Information
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Responsible Party: ZhuHai Cardionovum Medical Device Co., Ltd.
ClinicalTrials.gov Identifier: NCT02944890     History of Changes
Other Study ID Numbers: RG01W-1101
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2017

Additional relevant MeSH terms:
Coronary Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases