Last reviewed · How we verify
NCT05353946: CRATER
Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure
NA trial testing Percutaneous coronary intervention (PCI) in Coronary Artery Disease in 124 participants. Currently enrolling.
27 December 2022
Quick facts
| Lead sponsor | Guillermo Galeote; MD, PhD |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 124 |
| Start date | 2 February 2019 |
| Primary completion | 27 December 2022 |
| Estimated completion | 4 December 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Percutaneous coronary intervention (PCI)
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Chronic Renal Failure — all drugs for Chronic Renal Failure →
Sponsor
Guillermo Galeote; MD, PhD
Who can join
Adults 18 to 100, any sex, with Coronary Artery Disease or Chronic Renal Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05353946
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Coronary Artery Disease
Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05353946 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Guillermo Galeote; MD, PhD
- Last refreshed: 29 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05353946.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing