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New treatment option for Coronary Artery Disease
Official title Influence of Vessel Wall Calcification on Early Stent Strut Healing
ClinicalTrials.gov ID: NCT06631755
What this study is testing
- What it's testing
- To assess the influence of superficial calcium on the early endothelialization (1 month) of the struts of the Xience Skypoint stent (comparing struts with underlying superficial calcium to struts without underlying calcification)
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
- Patients who meet all the following conditions will be included:
- Patients aged ≥ 18 years old and;
- Patients with clinical indication for stent implantation and;
- Patients with OCT evaluation that shows the presence of calcified tissue underlying the lumen surface, fulfilling the definition of superficial...
- Patients with good quality baseline OCT evaluation as judged by the investigators and;
You likely can't join if
- Patients who meet, at least, 1 of the following conditions will be excluded:
- Patients with current ST-elevation Myocardial Infarction (STEMI).
- Patients with non-native lesion: stent restenosis, segment previously treated with drug eluting balloon, arterial or saphenous vein grafts.
- Patients with contraindication for the 1-month follow-up angiography and OCT:
- Glomerular Filtration Rate (GFR)\< 30 ml/min/1.72m2
- Contrast allergy
See the full eligibility criteria
- Patients who meet all the following conditions will be included:
- Patients aged ≥ 18 years old and;
- Patients with clinical indication for stent implantation and;
- Patients with OCT evaluation that shows the presence of calcified tissue underlying the lumen surface, fulfilling the definition of superficial calcium (The distance from the abluminal point of the calcium to the...
- Patients with good quality baseline OCT evaluation as judged by the investigators and;
- Patients who have been briefed on the study characteristics and have given their prior written informed consent.
- Patients who meet, at least, 1 of the following conditions will be excluded:
- Patients with current ST-elevation Myocardial Infarction (STEMI).
- Patients with non-native lesion: stent restenosis, segment previously treated with drug eluting balloon, arterial or saphenous vein grafts.
- Patients with contraindication for the 1-month follow-up angiography and OCT:
- Glomerular Filtration Rate (GFR)\< 30 ml/min/1.72m2
- Contrast allergy
- Baseline post-stent control OCT failure, due to tortuosity or any other reason.
- Patient not candidate for a follow up angiography, due to frailty, non-cardiac disease or whatever other condition considered by the local team.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
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 Barcelona, Spain. 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.