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Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease

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ClinicalTrials.gov Identifier: NCT02946307
Recruitment Status : Active, not recruiting
First Posted : October 27, 2016
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
R&G Pharma Studies Co.,Ltd.
Information provided by (Responsible Party):
ZhuHai Cardionovum Medical Device Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of RESTORE Paclitaxel eluting balloon in the treatment of Chinese patients with coronary heart disease and small vessel lesions in comparison with RESOLUTE Zotarolimus eluting stent.

Condition or disease Intervention/treatment Phase
Coronary Stenosis Device: Restore DEB(dimeter>2.00 mm) Device: Resolute DES Device: Restore DEB(dimeter:2.00 mm) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized, Controlled Clinical Trial, Assessing the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease in Chinese Population With Coronary Heart Disease
Study Start Date : August 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Experimental: small vessel cohort:Restore DEB
receiving the treatment with Restore DEB(dimeter>2.00 mm) in small vessel cohort
Device: Restore DEB(dimeter>2.00 mm)
Active Comparator: small vessel cohort:Resolute DES
receiving the treatment with Resolute DES in small vessel cohort
Device: Resolute DES
very small vessel cohort:Restore DEB
receiving the treatment with Restore DEB(dimeter:2.00 mm)in very small vessel cohort
Device: Restore DEB(dimeter:2.00 mm)



Primary Outcome Measures :
  1. In-segment diameter stenosis(%). [ Time Frame: 9 months after the operation. ]

Secondary Outcome Measures :
  1. The success rate of intervention treatment (%),including device success, lesion success and clinical success. [ Time Frame: 1-2 days. ]
  2. In-device diameter stenosis (%) of the target lesion. [ Time Frame: 9 months after the operation. ]
  3. cardiac death. [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5. ]
  4. myocardial infarction related to the target vessel. [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5. ]
  5. target lesion revascularization driven by ischemia. [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5. ]
  6. all-cause death [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5. ]
  7. myocardial infarction [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5. ]
  8. any target lesion revascularization [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5. ]
  9. acute thrombosis [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5 ]
  10. sub-acute thrombosis [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5 ]
  11. end-stage thrombosis [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5 ]
  12. delayed thrombosis [ Time Frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5 ]


Information from the National Library of Medicine

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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 with stable or unstable angina pectoris, or recent myocardial infarction which has been stabilized (occurred over 7 days before enrollment, including non-st segment elevation myocardial infarction(NSTMI) and STMI), or proved asymptomatic regional myocardial ischemia
  3. Patients in the small vessel cohort should be suitable for balloon dilation angioplasty or stent implantation, patients in the very small vessel cohort should be suitable for balloon dilation angioplasty.
  4. Patients should have sufficient compliance and agree to receive follow-ups in month-1, 6, 9 and 12, and follow-up visit in year-2, 3, 4, and 5. It is required to perform angiography in month-9.
  5. Patients should volunteer to participate in this study, and sign the written informed consent form, and understand all risks and benefits in the informed consent document.

    Related to the diseases:

  6. Patients with de novo, in situ lesions of small coronary vessels, the length of the lesion should be ≤26mm according to visual inspection. In the small vessel cohort, the diameter of the target lesion should be ≥2.25mm and ≤2.75mm according to visual inspection, and in the very small vessel cohort, the diameter of the target lesion should be ≥2. 00mm and <2.25mm according to visual inspection.
  7. The diameter stenosis according to visual inspection before intervention treatment should be ≥70% or ≥50% with the evidence of ischemia.
  8. Each patient is allowed to have only one lesion of the target small vessel (2 lesions with the distance ≤10mm and total length ≤26mm which could be treated with the same balloon or stent is considered as one lesion).

Exclusion Criteria:

Related to the patients:

  1. Myocardial infarction occurred within 1 week before enrollment.
  2. Patients with severe congestive heart failure or New York Heart Association (NYHA) grade IV heart failure
  3. Left ventricular ejection fraction (LVEF) <35%
  4. Patients who had heart transplantation
  5. Patients with severe valvular heart disease
  6. 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.
  7. 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)
  8. Patients with renal insufficiency (eGFR<30ml/min)
  9. Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel
  10. Patients who are known to be allergic to Paclitaxel or Zotarolimus
  11. The patients have a life expectancy of less than 1 year, or it would be difficult to finish follow-ups within 1 year.
  12. Pregnant or lactating women, or female patients at a child-bearing age who plan to get pregnant during the period of the study or could not take effective contraceptives
  13. The patients are participating in any clinical trials of other drugs or devices before reaching the primary endpoints.
  14. Patients who are unsuitable for the study according to the investigator due to other reasons

    Related to the diseases:

  15. Patients with total occlusion of the target vessel
  16. The patients have severe calcification of the target lesion, and therefore balloon pre-dilation could not be performed successfully.
  17. The target lesions are bifurcation lesion with the diameter of the branch vessel >2.00mm.
  18. The target lesions are in-stent restenosis.
  19. Angiography indicates thrombosis in the target vessel.
  20. Complicated with lesions in left main(LM) requiring intervention treatment
  21. There are more than 2 non-target lesions which require treatment, or could not be treated with intervention before the target lesion, or the treatment had failed.

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): NCT02946307


Locations
China, Beijing
Beijing Anzhen Hospital,Capital Medical University
Beijing, Beijing, China, 100029
Fuwai Hospital, CAMS&PUMC
Beijing, Beijing, China, 100037
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing, China, 100050
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
China, Heilongjiang
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China, 163000
China, Hubei
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430022
China, Hunan
Xiangya Hospital Central South University
Changsha, Hunan, China, 410008
China, Jiangsu
Nanjing Drum Tower Hospital, The Affiliated Hospital of Najing University Medical School
Nanjing, Jiangsu, China, 210008
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
China, Liaoning
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
China, Shaanxi
Tangdu Hospital
Xi'an, Shaanxi, China, 710038
China, Tianjin
Tianjin 4th Centre Hospital
Tianjin, Tianjin, China, 300140
Sponsors and Collaborators
ZhuHai Cardionovum Medical Device Co., Ltd.
R&G Pharma Studies Co.,Ltd.
Investigators
Principal Investigator: Runlin Gao, Master Fuwai Hospital, CAMS&PUMC

Responsible Party: ZhuHai Cardionovum Medical Device Co., Ltd.
ClinicalTrials.gov Identifier: NCT02946307     History of Changes
Other Study ID Numbers: RG01W-1102
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: October 2017

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Paclitaxel
Glucuronyl glucosamine glycan sulfate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs