Last reviewed · How we verify
NCT05801003: CUT-DRESS
Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation (CUT-DRESS).
NA trial testing Predilation with cutting balloon. in Coronary Artery Disease in 96 participants. Status unknown.
1 April 2024
Quick facts
| Lead sponsor | Hospital Universitario La Fe |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 96 |
| Start date | 1 February 2023 |
| Primary completion | 1 April 2024 |
| Estimated completion | 1 January 2025 |
| Sites | 3 locations across Spain |
Drugs / interventions tested
- Predilation with cutting balloon.
- Predilation with conventional balloon
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Percutaneous Coronary Intervention — all drugs for Percutaneous Coronary Intervention →
- Cutting Balloon — all drugs for Cutting Balloon →
Sponsor
Hospital Universitario La Fe
Who can join
Adults 18 to 99, any sex, with Coronary Artery Disease or Percutaneous Coronary Intervention. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Drug-eluting stents iterations has significantly improved the results of percutaneous revascularization among patients undergoing coronary revascularization thanks to thinner struts, more biocompatible polymer coatings and new drug release formulations; leading to lower thrombogenicity, faster reendothelialization and improved clinical outcomes. Notwithstanding, stent-related events yet occur. Lesion pre-dilation prior to DES implantation is a crucial procedural step as it creates microdissections, which are required for optimal uptake of the drug. However, the best pre-dilation strategy has not yet been determined. Therefore, the aim of this study is to evaluate a strategy based on pre-dilation with cutting balloon (CB) followed by Abluminus Sirolimus-eluting stent (ASES) implantation for de novo coronary lesions
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05801003
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Hospital Universitario La Fe trials
Trials by the same sponsor.
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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 NCT05801003 (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 Hospital Universitario La Fe
- Last refreshed: 1 March 2024
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/NCT05801003.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing