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Compares treatment options for PCI
Official title Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions
ClinicalTrials.gov ID: NCT07093788
What this study is testing
- What it's testing
- this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions
- 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
- Age \> 18 years and \< 80 years
- Presented as asymptomatic angina, stable angina, unstable angina, prior myocardial infarction (MI), or non-ST-elevation myocardial infarction...
- Have an indication for drug-eluting stent (DES) implantation
- Denovo coronary artery calcified lesions
- Target lesion diameter stenosis ≥ 70%, or target lesion diameter stenosis between ≥ 50% and \< 70%, accompanied by evidence of myocardial...
You likely can't join if
- Presented as acute ST-segment elevation myocardial infarction (STEMI), cardiogenic shock and multiple organ failure
- Presented as severe contrast agent allergy
- Intolerant to dual antiplatelet therapy (DAPT) and/or anticoagulation therapy
- Presented as active phase of autoimmune disease
- Calcified nodules or eccentric calcification lesions
- Failure to reach the target lesion with guidewires or catheters
See the full eligibility criteria
- Age \> 18 years and \< 80 years
- Presented as asymptomatic angina, stable angina, unstable angina, prior myocardial infarction (MI), or non-ST-elevation myocardial infarction (NSTEMI).
- Have an indication for drug-eluting stent (DES) implantation
- Denovo coronary artery calcified lesions
- Target lesion diameter stenosis ≥ 70%, or target lesion diameter stenosis between ≥ 50% and \< 70%, accompanied by evidence of myocardial ischemia(such as fractional flow reserve (FFR) ≤ 0.80 or minimal lumen area (MLA)...
- Reference vessel diameter of the target vessel between 2.5 mm - 4.5 mm
- Maximum calcium arc within the lesion ≥ 270⁰ assessed by optical coherence tomography (OCT) or intravascular ultrasound (IVUS)
- Unsatisfactory lesion preparation with non-compliant balloon, defined as baseline diameter stenosis reduction of \< 30% under maximal inflation pressure.
- Provision of written informed consent
- Presented as acute ST-segment elevation myocardial infarction (STEMI), cardiogenic shock and multiple organ failure
- Presented as severe contrast agent allergy
- Intolerant to dual antiplatelet therapy (DAPT) and/or anticoagulation therapy
- Presented as active phase of autoimmune disease
- Calcified nodules or eccentric calcification lesions
- Failure to reach the target lesion with guidewires or catheters
- Complex coronary bifurcation lesions
- Target vessel thrombosis or aneurysm within 10 mm of the target lesion
The study team makes the final eligibility decision.
Where it's taking place
- Lianyungang, Jiangsu, China
- Nanjing, Jiangsu, China
- Yixing, Jiangsu, 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 Lianyungang, Jiangsu, China; Nanjing, Jiangsu, China; Yixing, Jiangsu, China. 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.