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New treatment option for Coronary Artery Disease
Official title Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure
ClinicalTrials.gov ID: NCT05353946
What this study is testing
- What it's testing
- The current role of the rotational atherectomy is for non-dilatable coronary lesions and for severely calcified lesions that may interfere with optimal stent expansion. Severely calcified coronary lesions are associated with worse outcomes.
- 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
- Patients \>18 years.
- Glomerular filtration rate (GFR) \<60 mL/min/1.73 m2 for 3 months or more
- Stenosis ≥70% in a coronary artery with a diameter ≥2,5 mm.
- Severe angiographic calcification (affecting both sides of the arterial lumen)
- Any clinical scenario except acute myocardial infarction in the first seven days of evolution.
You likely can't join if
- Absence of informed consent.
- Acute myocardial infarction in the first 7 days of evolution.
- Lesion in a single patent vessel.
- Calcified lesions with an angulation \>60º, dissections, lesions with thrombus, and degenerated saphenous vein grafts.
- Hemodynamically unstable patients
- Patients with allergy to iodinated contrast media
See the full eligibility criteria
- Patients \>18 years.
- Glomerular filtration rate (GFR) \<60 mL/min/1.73 m2 for 3 months or more
- Stenosis ≥70% in a coronary artery with a diameter ≥2,5 mm.
- Severe angiographic calcification (affecting both sides of the arterial lumen)
- Any clinical scenario except acute myocardial infarction in the first seven days of evolution.
- Native coronary vessel or bypass graft.
- Absence of informed consent.
- Acute myocardial infarction in the first 7 days of evolution.
- Lesion in a single patent vessel.
- Calcified lesions with an angulation \>60º, dissections, lesions with thrombus, and degenerated saphenous vein grafts.
- Hemodynamically unstable patients
- Patients with allergy to iodinated contrast media
- Patients with significant comorbidity and with a life expectancy of less than one year
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, 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 to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, 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.