CRATER Trial: Coronary Rotational Atherectomy Elective vs. Bailout in Patients With Severely Calcified Lesions and Chronic Renal Failure

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
La Paz University Hospital
RECRUITING
Madrid
Contact Information
Primary
Guillermo Galeote, PhD, MD
ggaleote1@gmail.com
+34609024315
Backup
Artemio García-Escobar, MD
dr_garciaescobar@hotmail.com
+34608936547
Time Frame
Start Date: 2019-02-02
Estimated Completion Date: 2023-12-04
Participants
Target number of participants: 124
Treatments
Active_comparator: Elective Rotational Atherectomy
Operators can decide elective use of rotational atherectomy (RA) or conventional angioplasty according to the calcification patterns of the coronary lesion evaluated by Intravascular ultrasound (IVUS) or by angiography if the IVUS cannot cross the lesion.~Procedure is performed with a Rotablator system, consisting of a rotating olive-shaped burr whose leading hemisphere is coated with microscopic diamond chips. The proximal end of the device has a housing unit containing the burr advancer, a fiberoptic tachometer cable, an irrigation port, and a nitrogen gas delivery hose, which permits the rapidly rotating of the burr. The RA catheter is introduced into the coronary artery over a stainless steel 0.09-inch wire to cross the lesion, then advanced with a slow pecking motion at a speed of 160,000 to 190,000 rpm with each ablation run \<15 seconds is performed. Burr size was with a burr/vessel ratio of 0.7. After RA, all patients received IVUS-guided percutaneous coronary intervention.
Active_comparator: Bailout Rotational Atherectomy
The operators began with conventional angioplasty (non-compliant balloon dilatation) regardless of the calcification patterns in the coronary lesion, and rotational atherectomy (RA) can be used only as a bailout.
Sponsors
Leads: Guillermo Galeote; MD, PhD

This content was sourced from clinicaltrials.gov