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Synergy® Stent + DAPT for Coronary Artery Disease (SYNIVUS-DAPT Trial)
SYNIVUS-DAPT Trial Summary
This trial will test if a new stent is safe for patients who are at high risk for bleeding.
SYNIVUS-DAPT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SYNIVUS-DAPT Trial Design
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Who is running the clinical trial?
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- You have a blood clot, or a potential blood clot, in the specific blood vessel being studied.You are currently taking part in a research study for a new medication or medical device that has not finished its main goal.The target lesion has a complicated split or division.You need treatment for more than two large heart blood vessels.You currently have a stomach ulcer or bleeding in your stomach or intestines.You have had a Synergy Stent implanted and used Boston Scientific IVUS to guide the stent implantation.Any stents that were placed in the body must meet certain criteria for success when examined with a special imaging test called IVUS.The blood vessel must be between 2.25 mm and 4.0 mm in diameter, and the affected area must be no longer than 34mm.You have a condition called Non ST elevation MI (NSTEMI) according to a specific medical definition.You have received a different type of coronary stent, other than the SYNERGY Stent, during a previous procedure.You have received intravascular brachytherapy treatment before.You are not able to stop taking a certain type of medication called P2Y12 inhibitor after one month.You have received a drug-coated stent other than SYNERGY Stent within 11 months before the study.Your blood flow in a specific artery is completely blocked.You are at a high risk for bleeding based on certain criteria.You have blockages in more than three arteries around your heart, unless they can all be treated with one stent.The area where a stent was placed in your body has become narrow again.You have received treatment for lesions that are not the main focus of the study or were not treated with a Synergy stent.You did not have a stent implanted and assessed using Boston Scientific IVUS guidance.Any specific abnormal area in your body that has not been treated with a certain type of medical procedure.The area to be treated is in a vein or artery that has been surgically replaced.The tumor is in the left main part of the body.You have a surgery or procedure coming up that will require you to stop taking a certain medication for at least one month.You have a medical condition that doctors expect to significantly shorten your life.You have a condition called acute ST elevation myocardial infarction (STEMI).You have a scheduled surgery more than 7 days after the first procedure.
- Group 1: PCI with 30 day DAPT Therapy
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is enrollment still open for this clinical experiment?
"Reportedly, this study is no longer recruiting candidates. The trial was first submitted on November 19th 2018 and last updated February 15th 2022; despite the fact that it is not actively looking for participants, there are 642 other clinical trials enrolling at present."
Is enrollment for this trial still open, and if so, how can I join?
"This medical experiment is seeking 50 participants aged 18 to 75 with a history of atherogenesis. To be eligible, they must have experienced severe or moderate bleeding within the past year according to GUSTO classification, been implanted at least one Synergy Stent and had Boston Scientific IVUS guidance for implantation, be over 75 years old and judged as having an elevated risk of falling by investigators, plus not abuse drugs or alcohol."
Has the Food and Drug Administration given its seal of approval to Dual Antiplatelet Therapy?
"Due to its status as a Phase 2 trial, with data suggesting safety but none demonstrating efficacy, Dual Antiplatelet (DAPT) Therapy garnered an assessment of 2."
What results is this research aiming to achieve?
"This study, which spans 1 to 13 months in duration, is primarily designed to measure the rate of cardiac death. Additional metrics include Angina Assessment for All-Cause MI and Ischemia-Driven Target Vessel/Lesion Revascularization."
Does the research encompass participants aged fifty and above?
"This research requires patients aged between 18 and 75 to be considered. There are 20 studies that involve participants younger than 18, while those above 65 can be found in 625 trials."
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