BridgeMD
New treatment option for Coronary Artery Disease
Official title Optimal Stent Deployment Strategy of Contemporary Stents
ClinicalTrials.gov ID: NCT05292651
What this study is testing
- What it's testing
- The primary objective is to evaluate whether a standard pre- and postdilatation (PSP strategy) of the modern DES results in a more optimal stent implantation compared to DS as evaluated by OCT in patients with stable coronary artery disease. The secondary clinical objective is to evaluate clinical cardiovascular outcomes in patients with stable coronary artery disease treated with the PSP strategy.
- 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 100
You may be able to join if
- Stable angina patients or acute coronary syndrome patients with bystander stable coronary artery disease
- With one or more significant epicardial stenosis in native coronary arteries suitable for direct stenting, according to the judgement of treating...
- Subject must be at least 18 years of age
- Written consent to participate in the study
You likely can't join if
- Lesions not suitable for direct stenting, like (sub)-total stenosis, severely calcified lesions
- Culprit lesions of acute coronary syndrome cannot be assigned by chance to the trial. After successful treatment of the ACS culprit lesion, patients...
- Lesions not suitable for OCT catheter delivery and imaging, e.g. left main or ostial right coronary artery stenosis, lesions in coronary bypass...
- Treatment for in-stent restenosis
- Bifurcation lesions in which a two-stent technique or a proximal postdilatation is planned.
- Treatment of coronary artery bypass grafts
See the full eligibility criteria
- Stable angina patients or acute coronary syndrome patients with bystander stable coronary artery disease
- With one or more significant epicardial stenosis in native coronary arteries suitable for direct stenting, according to the judgement of treating operator. The use of fractional flow reserve (FFR) or resting indices...
- Subject must be at least 18 years of age
- Written consent to participate in the study
- Lesions not suitable for direct stenting, like (sub)-total stenosis, severely calcified lesions
- Culprit lesions of acute coronary syndrome cannot be assigned by chance to the trial. After successful treatment of the ACS culprit lesion, patients however can be assigned by chance in the trial in case of remaining...
- Lesions not suitable for OCT catheter delivery and imaging, e.g. left main or ostial right coronary artery stenosis, lesions in coronary bypass grafts or tortuous anatomy
- Treatment for in-stent restenosis
- Bifurcation lesions in which a two-stent technique or a proximal postdilatation is planned.
- Treatment of coronary artery bypass grafts
- Creatine Clearance ≤ 30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR)
- Known hypersensitivity or allergy for cobalt chromium
- Known comorbidity associated with a life expectancy \< 1 year
- Unable to understand and follow study-related instructions or unable to comply with study protocol
The study team makes the final eligibility decision.
Where it's taking place
- Dordrecht, 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 to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dordrecht, 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.