BridgeMD
New treatment option for Acute Coronary Syndrome (ACS)
Official title Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)
ClinicalTrials.gov ID: NCT06365502
What this study is testing
What is Guideline-directed medical treatment?
Guideline-directed medical treatment is an investigational medicine, being studied as a potential treatment for acute coronary syndrome (acs).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- people 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...
- 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
You likely can't join if
- Subject has known hypersensitivity or contraindication to any of the study drugs (including all asprin, P2Y12 inhibitors, one or more components of...
- Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive...
- 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...
- Life expectancy \<2 years for any
See the full eligibility criteria
- people 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 \ 180°
- Subject must provide written informed consent before any study-related procedure
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijin, Beijing Municipality, China
- Zunyi, Guizhou, China
- Daqing, Heilongjiang, China
- Harbin, Heilongjiang, China
- Jiamusi, Heilongjiang, China
- Mudanjiang, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changchun, Jilin, China
- Dalian, Liaoning, China
- Shengyang, Liaoning, China
- Hohhot, Neimenggu, China
- Jinan, Shandong, China
- Jining, Shandong, China
- Qingdao, Shandong, China
- Yantai, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijin, Beijing Municipality, China; Zunyi, Guizhou, China; Daqing, Heilongjiang, China; Harbin, Heilongjiang, China; Jiamusi, Heilongjiang, China; Mudanjiang, Heilongjiang, China and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.