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

NCT02946307 | Completed

• 1 other identifier: RG01W-1102
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 12

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.

Conditions

Coronary Stenosis

Outcome Measures

Primary Outcomes (1)

• In-segment diameter stenosis(%).

  9 months after the operation.

Secondary Outcomes (12)

• 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.

Study Arms (3)

small vessel cohort:Restore DEB

EXPERIMENTAL

receiving the treatment with Restore DEB（dimeter\>2.00 mm） in small vessel cohort

Device: Restore DEB（dimeter>2.00 mm）

small vessel cohort:Resolute DES

ACTIVE COMPARATOR

receiving the treatment with Resolute DES in small vessel cohort

Device: Resolute DES

very small vessel cohort:Restore DEB

OTHER

receiving the treatment with Restore DEB（dimeter:2.00 mm）in very small vessel cohort

Device: Restore DEB（dimeter:2.00 mm）

Interventions

Restore DEB（dimeter:2.00 mm） DEVICE

very small vessel cohort:Restore DEB

Resolute DES DEVICE

small vessel cohort:Resolute DES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Related to the patients:
• Age ≥18 years old
• 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
• 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.
• 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.
• 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:
• 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.
• The diameter stenosis according to visual inspection before intervention treatment should be ≥70% or ≥50% with the evidence of ischemia.
• 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).

You may not qualify if:

• Related to the patients:
• Myocardial infarction occurred within 1 week before enrollment.
• Patients with severe congestive heart failure or New York Heart Association (NYHA) grade IV heart failure
• Left ventricular ejection fraction (LVEF) \<35%
• Patients who had heart transplantation
• Patients with severe valvular heart disease
• 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.
• 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)
• Patients with renal insufficiency (eGFR\<30ml/min)
• Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel
• Patients who are known to be allergic to Paclitaxel or Zotarolimus
• The patients have a life expectancy of less than 1 year, or it would be difficult to finish follow-ups within 1 year.
• 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
• The patients are participating in any clinical trials of other drugs or devices before reaching the primary endpoints.
• Patients who are unsuitable for the study according to the investigator due to other reasons

Sponsors & Collaborators

• ZhuHai Cardionovum Medical Device Co., Ltd.: lead
• R&G Pharma Studies Co.,Ltd.: collaborator

Study Sites (12)

Beijing Anzhen Hospital,Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, 100037, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Daqing Oilfield General Hospital

Daqing, Heilongjiang, 163000, China

Location

Wuhan Asia Heart Hospital

Wuhan, Hubei, 430022, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

Nanjing Drum Tower Hospital, The Affiliated Hospital of Najing University Medical School

Nanjing, Jiangsu, 210008, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

Location

Tianjin 4th Centre Hospital

Tianjin, Tianjin Municipality, 300140, China

Location

Related Publications (2)

• 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.

  PMID: 33227335 DERIVED

• 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.

  PMID: 30522667 DERIVED

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Runlin Gao, Master

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 27, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: May 1, 2019
• Last Updated: July 29, 2019

Record last verified: 2018-10

Locations

CN (12)