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NCT Number: NCT06365502

Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)

The objective of this multicenter, prospective, open-label, controlled, randomized trial is to demonstrate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in improving clinical cardiovascular outcomes in patients with acute coronary syndrome.

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Key information

Conditions

Acute Coronary Syndrome (ACS) Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Beijing Luhe Hospital of Capital Medical University, Beijin, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must be between 18 and 80 years of age
  • Subject must present with acute myocardial infarction or unstable angina planned for PCI
  • Successful stent implantation (i.e., residual stenosis less than 20%) must be done in culprit lesions and any lesions with ischemia evidence (e.g., QFR equal or less than 0.8)
  • Subject must have at least one native non-culprit lesion with visually estimated stenosis of 40-80% and QFR >0.8
  • Target lesion must have a visually estimated diameter of 2.0-4.0 mm and length of ≤ 50 mm
  • Target lesion must have any two of the intravascular imaging criteria of PB >65%, MLA <3.5 mm^2 (OCT) or 4.0mm^2 (IVUS), FCT <75 μm, or maximal lipid arc >180°
  • Subject must provide written informed consent before any study-related procedure

Exclusion criteria

  • Subject has known hypersensitivity or contraindication to any of the study drugs (including all asprin, P2Y12 inhibitors, one or more components of the study devices, including paclitaxel, etc) that cannot be adequately pre-medicated
  • Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.)
  • Hypotension, shock, or need for mechanical support or intravenous vasopressors;
  • Creatinine clearance ≤30 ml/min/1.73 m^2 (as calculated by MDRD formula for estimated GFR)
  • Left ventricular ejection fraction<30% by the most recent imaging test within 30 days before procedure (echo, MRI, contrast left ventriculography or others)
  • Life expectancy <2 years for any
  • Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  • The target lesion is located within 10 mm of the proximal or distal of stent
  • The target lesion cannot be in the left main coronary artery
  • The target lesion is located in a bifurcation lesion (i.e., the diameter of the branch vessels is >2 mm with >50% of stenosis)
  • The target lesion is located in severe calcification or tortuosity of vessels
  • The target lesion involved in the ostium of LAD, LCX or RCA (within 3 mm of the ostium)
  • The target lesion is located within the bypass graft artery

Treatment and study plan

Drug-coated Balloon

Device

Non-culprit lesion will be pretreated before DCB treatment. The bail-out stent treatment is permitted if pretreatment failed.

Guideline-directed medical treatment

Drug

All individuals will receive guideline-directed medical treatment.

Primary outcomes

  1. Target lesion failure (TLF)

    Time frame: At 24 months

Secondary outcomes

  1. Target lesion failure (TLF)

    Time frame: At 30 days

  2. Target lesion failure (TLF)

    Time frame: At 6 months

  3. Target lesion failure (TLF)

    Time frame: At 12 months

  4. Major cardiac adverse event (MACE)

    Time frame: At 30 days

    MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina

  5. Major cardiac adverse event (MACE)

    Time frame: At 6 months

    MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina

  6. Major cardiac adverse event (MACE)

    Time frame: At 12 months

    MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina

  7. Major cardiac adverse event (MACE)

    Time frame: At 24 months

    MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina

  8. All-cause death

    Time frame: At 30 days

    Any death will be recorded as all-cause death

  9. All-cause death

    Time frame: At 6 months

    Any death will be recorded as all-cause death

  10. All-cause death

    Time frame: At 12 months

    Any death will be recorded as all-cause death

  11. All-cause death

    Time frame: At 24 months

    Any death will be recorded as all-cause death

  12. Cardiac death and target lesion MI

    Time frame: At 30 days

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment

  13. Cardiac death and target lesion MI

    Time frame: At 6 months

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment

  14. Cardiac death and target lesion MI

    Time frame: At 12 months

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment

  15. Cardiac death and target lesion MI

    Time frame: At 24 months

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment

  16. Cardiac death

    Time frame: At 30 days

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment

  17. Cardiac death

    Time frame: At 6 months

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment

  18. Cardiac death

    Time frame: At 12 months

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment

  19. Cardiac death

    Time frame: At 24 months

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment

  20. Target lesion myocardial infarction

    Time frame: At 30 days

    Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed

  21. Target lesion myocardial infarction

    Time frame: At 6 months

    Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed

  22. Target lesion myocardial infarction

    Time frame: At 12 months

    Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed

  23. Target lesion myocardial infarction

    Time frame: At 24 months

    Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed

  24. Periprocedural myocardial infarction

    Time frame: At 30 days

    Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed.

  25. Periprocedural myocardial infarction

    Time frame: At 6 months

    Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed.

  26. Periprocedural myocardial infarction

    Time frame: At 12 months

    Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed.

  27. Periprocedural myocardial infarction

    Time frame: At 24 months

    Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed.

  28. Periprocedural and non-periprocedural myocardial infarction

    Time frame: At 30 days

    Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed

  29. Periprocedural and non-periprocedural myocardial infarction

    Time frame: At 6 months

    Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed

  30. Periprocedural and non-periprocedural myocardial infarction

    Time frame: At 12 months

    Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed

  31. Periprocedural and non-periprocedural myocardial infarction

    Time frame: At 24 months

    Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed

  32. Target vessel failure (TVF)

    Time frame: At 30 days

    TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization.

  33. Target vessel failure (TVF)

    Time frame: At 6 months

    TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization.

  34. Target vessel failure (TVF)

    Time frame: At 12 months

    TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization.

  35. Target vessel failure (TVF)

    Time frame: At 24 months

    TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization.

  36. Minimal lumen area after DCB treatment

    Time frame: At baseline

    Post-procedure imaging examination is required

  37. Plaque burden after DCB treatment

    Time frame: At baseline

    Post-procedure imaging examination is required

  38. FCT after DCB treatment

    Time frame: At baseline

    Post-procedure imaging examination is required

  39. Lipid arc after DCB treatment

    Time frame: At baseline

    Post-procedure imaging examination is required

  40. FCT <75 μm after DCB treatment

    Time frame: At baseline

    Post-procedure imaging examination is required

  41. PB >65% after DCB treatment

    Time frame: At baseline

    Post-procedure imaging examination is required

  42. PB >70% after DCB treatment

    Time frame: At baseline

    Post-procedure imaging examination is required

  43. MLA <3.5 mm^2 after DCB treatment

    Time frame: At baseline

    Post-procedure imaging examination is required

  44. Maximal lipid arc >180° after DCB treatment

    Time frame: At baseline

    Post-procedure imaging examination is required

  45. Cardiac biomarkers: GDF-15, interleukin-6, interleukin-1β and ceramide etc.

    Time frame: At baseline and one-year follow-up

    The centers with sample preservation qualifications will be asked to preserve blood samples.

Study contacts

Contact information is provided by the study sponsor or research team.

Haibo Jia, PhD

CONTACT

[email protected]

15945685291

Sponsors and collaborators

Lead sponsor

Harbin Medical University

Other

Collaborators

  • Shanghai Shenqi Medical Technology Co., Ltd

Registry information

Official study title

A Multicenter, Prospective, Open-label, Controlled, Randomized Trial of Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Apr 15, 2024
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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