Clinical trial for Coronary Artery Disease
Official title Post-Marketing Clinical Study of High-Pressure Cutting Balloon
ClinicalTrials.gov ID: NCT07835178
What this study is testing
- What it's testing
- This study is designed as a prospective, multicenter, 1:1 randomized controlled trial. It plans to enroll 280 patients with moderate-to-severe calcified coronary lesions who are candidates for IVUS-guided DES implantation.
- 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
- Age ≥18 years;
- Patients with coronary artery disease who indicate IVUS-guided drug-eluting stent implantation;
- Moderate-to-severe calcified lesions on coronary angiography;
- Target lesion is a de novo lesion in a native vessel that has not received any prior treatment treatment;
- Target vessel diameter of 2.5-4.0 mm, with guidewire crossing of the target lesion;
You likely can't join if
- Life expectancy \<1 year;
- Cardiogenic shock or hemodynamic instability;
- Left main coronary artery disease;
- Chronic total occlusion;
- Bifurcation lesions planned for a "two-stent strategy";
- Active bleeding;
See the full eligibility criteria
- Age ≥18 years;
- Patients with coronary artery disease who indicate IVUS-guided drug-eluting stent implantation;
- Moderate-to-severe calcified lesions on coronary angiography;
- Target lesion is a de novo lesion in a native vessel that has not received any prior treatment treatment;
- Target vessel diameter of 2.5-4.0 mm, with guidewire crossing of the target lesion;
- In patients with multiple lesions, only one lesion will be selected as the target lesion in this study. If target and non-target lesions are treated during the same procedure, the target and non-target lesions must be...
- Provision of written informed consent.
- Life expectancy \<1 year;
- Cardiogenic shock or hemodynamic instability;
- Left main coronary artery disease;
- Chronic total occlusion;
- Bifurcation lesions planned for a "two-stent strategy";
- Active bleeding;
- Known history of allergy to contrast media or metals;
- Patients with a bleeding tendency, contraindications to antiplatelet or anticoagulant therapy, or inability to receive anticoagulation therapy;
- New-onset stroke/transient ischemic attack within 6 months;
- Pregnant or lactating women;
- Left ventricular ejection fraction \<25%, or NYHA functional class IV, or Killip class ≥2;
- Non-target vessel revascularization within 30 days before randomization with complications.
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, 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.