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Coronary StenosisNCT02946307

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

A study testing Restore DEB（dimeter>2.00 mm）, Resolute DES and Restore DEB（dimeter:2.00 mm） in people with Coronary Stenosis, run by ZhuHai Cardionovum Medical Device Co., Ltd. at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Stenosis
What is being tested?
Restore DEB（dimeter>2.00 mm）, Resolute DES and Restore DEB（dimeter:2.00 mm）
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
12 sitesChina
Study dates
Aug 2016to May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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
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  • 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
  • Related to the diseases:
  • Patients with total occlusion of the target vessel
  • The patients have severe calcification of the target lesion, and therefore balloon pre-dilation could not be performed successfully.
  • The target lesions are bifurcation lesion with the diameter of the branch vessel >2.00mm.
  • The target lesions are in-stent restenosis.
  • Angiography indicates thrombosis in the target vessel.
  • Complicated with lesions in left main(LM) requiring intervention treatment
  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Beijing Anzhen Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100029

  • Fuwai Hospital, CAMS&PUMC

    Beijing, Beijing Municipality, 100037

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang, 163000

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

    Nanjing, Jiangsu, 210008

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • Tianjin 4th Centre Hospital

    Tianjin, Tianjin Municipality, 300140

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei, 430022

  • Tangdu Hospital

    Xi'an, Shaanxi, 710038

Other trials in China

About this study

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

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.

Being tested
Restore DEB（dimeter>2.00 mm）, Resolute DES, Restore DEB（dimeter:2.00 mm）
Medical subject headings
Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Restore DEB（dimeter>2.00 mm）Device

  • Resolute DESDevice

  • Restore DEB（dimeter:2.00 mm）Device

Study groups in NCT02946307
Study groupRoleWhat they receive
small vessel cohort:Restore DEBExperimentalreceiving the treatment with Restore DEB（dimeter>2.00 mm） in small vessel cohort
Receives: Device: Restore DEB（dimeter>2.00 mm）
small vessel cohort:Resolute DESActive comparatorreceiving the treatment with Resolute DES in small vessel cohort
Receives: Device: Resolute DES
very small vessel cohort:Restore DEBOtherreceiving the treatment with Restore DEB（dimeter:2.00 mm）in very small vessel cohort
Receives: Device: Restore DEB（dimeter:2.00 mm）

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-segment diameter stenosis(%).

    Measured: 9 months after the operation.

Secondary outcomes (12)

  1. The success rate of intervention treatment (%),including device success, lesion success and clinical success.

    Measured: 1-2 days.

  2. In-device diameter stenosis (%) of the target lesion.

    Measured: 9 months after the operation.

  3. cardiac death.

    Measured: in month-1, 6, 9, 12 and year-2, 3, 4, 5.

  4. myocardial infarction related to the target vessel.

    Measured: in month-1, 6, 9, 12 and year-2, 3, 4, 5.

  5. target lesion revascularization driven by ischemia.

    Measured: in month-1, 6, 9, 12 and year-2, 3, 4, 5.

  6. all-cause death

    Measured: in month-1, 6, 9, 12 and year-2, 3, 4, 5.

  7. myocardial infarction

    Measured: in month-1, 6, 9, 12 and year-2, 3, 4, 5.

  8. any target lesion revascularization

    Measured: in month-1, 6, 9, 12 and year-2, 3, 4, 5.

  9. acute thrombosis

    Measured: in month-1, 6, 9, 12 and year-2, 3, 4, 5

  10. sub-acute thrombosis

    Measured: in month-1, 6, 9, 12 and year-2, 3, 4, 5

  11. end-stage thrombosis

    Measured: in month-1, 6, 9, 12 and year-2, 3, 4, 5

  12. delayed thrombosis

    Measured: in month-1, 6, 9, 12 and year-2, 3, 4, 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionDec 2018
  4. Study completionMay 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02946307
Sponsor's protocol ID
RG01W-1102
Status last verified
Oct 2018
First submitted
24 Oct 2016
Last updated
29 Jul 2019
Results posted
No

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.

    PubMed 33227335

  • 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.

    PubMed 30522667

Questions about this trial

What is this clinical trial studying?

A study testing Restore DEB（dimeter>2.00 mm）, Resolute DES and Restore DEB（dimeter:2.00 mm） in people with Coronary Stenosis, run by ZhuHai Cardionovum Medical Device Co., Ltd. at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-segment diameter stenosis(%). (time frame: 9 months after the operation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02946307, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.

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