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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Stenosis
• Intervention / Treatment: Device: Restore DEB（dimeter>2.00 mm）; Device: Resolute DES; Device: Restore DEB（dimeter:2.00 mm）

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital
    • Beijing, Beijing, China, 100037
      • Fuwai Hospital, CAMS&PUMC
    • Beijing, Beijing, China, 100029
      • Beijing Anzhen Hospital，Capital Medical University
  • Heilongjiang
    • Daqing, Heilongjiang, China, 163000
      • Daqing oilfield general hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Asia Heart Hospital
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital, The Affiliated Hospital of Najing University Medical School
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital of China Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Tangdu Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300140
      • Tianjin 4th Centre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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
Other: 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）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-segment diameter stenosis(%).	9 months after the operation.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ZhuHai Cardionovum Medical Device Co., Ltd.
• Collaborators: R&G Pharma Studies Co.,Ltd.
• Investigators: Principal Investigator: Runlin Gao, Master, Fuwai Hospital, CAMS&PUMC

Publications and helpful links

General Publications

• Li L, Guan C, Meng S, Bai Y, Zhang Z, Zou K, Ruan Y, Cao X, Jia R, Guo C, Escaned J, Jin Z, Xu B. Short- and long-term functional results following drug-coated balloons versus drug- eluting stents in small coronary vessels: The RESTORE quantitative flow ratio study. Int J Cardiol. 2021 Mar 15;327:45-51. doi: 10.1016/j.ijcard.2020.11.035. Epub 2020 Nov 21.
• Tang Y, Qiao S, Su X, Chen Y, Jin Z, Chen H, Xu B, Kong X, Pang W, Liu Y, Yu Z, Li X, Li H, Zhao Y, Wang Y, Li W, Tian J, Guan C, Xu B, Gao R; RESTORE SVD China Investigators. Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease: The RESTORE SVD China Randomized Trial. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2381-2392. doi: 10.1016/j.jcin.2018.09.009.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimate): October 27, 2016

Study Record Updates

• Last Update Posted (Actual): July 29, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Stenosis
• Other Study ID Numbers: RG01W-1102