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New treatment option for Coronary Artery Disease
Official title Drug-Eluting Balloon Treatment vs. Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques
ClinicalTrials.gov ID: NCT07107971
What this study is testing
- What it's testing
- The goal of this clinical trial is to find out whether treating vulnerable plaques in the coronary arteries with a drug-coated balloon can make them less dangerous than using standard medication alone. The study includes adults with acute coronary syndrome (a type of heart problem caused by reduced blood flow in the coronary arteries).
- 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 and older
You may be able to join if
- Presenting with acute coronary syndrome (ACS);
- Successful PCI of a native coronary artery or major side branch;
- At least 2 native coronary arteries are accessible for invasive coronary imaging; i.e. not totally occluded and \>2 mm and \<6 mm reference vessel...
You likely can't join if
- Hemodynamically unstable (presence of cardiogenic shock, need for intubation, need for inotropes);
- Known hypersensitivity to paclitaxel;
- Procedural complications of the index PCI;
- Known renal insufficiency, i.e. eGFR \<30 mL/min/1.73 m2;
- Hypersensitivity or allergy to contrast with inability to administer steroid and antihistamine premedication;
- Presence of a comorbid condition with a life expectancy of less than one year;
See the full eligibility criteria
- Presenting with acute coronary syndrome (ACS);
- Successful PCI of a native coronary artery or major side branch;
- At least 2 native coronary arteries are accessible for invasive coronary imaging; i.e. not totally occluded and \>2 mm and \<6 mm reference vessel diameter.
- Hemodynamically unstable (presence of cardiogenic shock, need for intubation, need for inotropes);
- Known hypersensitivity to paclitaxel;
- Procedural complications of the index PCI;
- Known renal insufficiency, i.e. eGFR \<30 mL/min/1.73 m2;
- Hypersensitivity or allergy to contrast with inability to administer steroid and antihistamine premedication;
- Presence of a comorbid condition with a life expectancy of less than one year;
- Body weight \>250 kg;
- Subject belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or is unable to read or write.
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. 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.