NCT05353946Recruiting
Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure
CRATER Trial: Coronary Rotational Atherectomy Elective vs. Bailout in Patients With Severely Calcified Lesions and Chronic Renal Failure
Source: ClinicalTrials.gov · Last updated 29 Apr 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. In this regard, chronic kidney disease is associated with severely calcified coronary arteries. Some evidence suggests that elective rotational atherectomy used by experienced operators can be safe and effective, minimizing time and complications for patients with heavily calcified lesions. However, there is no direct randomized comparison between rotational atherectomy and angioplasty alone in the setting of chronic renal failure and with intravascular ultrasound assessment for detecting severely calcified coronary arteries.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 6 Apr 2022
- Start date
- 2 Feb 2019
- Primary completion date
- 27 Dec 2022
- Lead sponsor
- Guillermo Galeote; MD, PhD
- NCT number
- NCT05353946
What you commit to
- Study type: Interventional
- Planned participants: 124
- From 2 Feb 2019 to the primary completion date, 27 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Acute myocardial infarction in the first 7 days of evolution.
- Patients with allergy to iodinated contrast media
Other
- Absence of informed consent.
- 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 significant comorbidity and with a life expectancy of less than one year
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| La Paz University Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.