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NCT05759676
Efficacy and Safety of Polymer-free Amphilimus-eluting Stent According to the Diabetes
trial testing Cre8™/Cre8™ EVO drug-eluting stent in Diabetes Mellitus in 1,800 participants. Currently enrolling.
31 August 2026
Quick facts
| Lead sponsor | Korea University Anam Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 1,800 |
| Start date | 9 March 2023 |
| Primary completion | 31 August 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Cre8™/Cre8™ EVO drug-eluting stent
Conditions studied
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
Sponsor
Korea University Anam Hospital
Who can join
19 and older, any sex, with Diabetes Mellitus or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Drug-eluting stents (DES) have been found to reduce the rate of stent restenosis compared to bare metal stents (BMS), but the first generation DES caused an increase in stent thrombosis. The second generation DES, including the Cre8Evo stent, has been designed to address these issues. The Cre8Evo stent is made of cobalt chromium and releases the drug amphilimus into the vessel wall, which is quickly absorbed and then lost, creating a BMS-like form. The Cre8Evo stent does not contain polymers and does not induce an inflammatory response. It inhibits cdk2 and RhoA, reducing the proliferation and migration of vascular smooth muscle cells. In diabetic patients, the Cre8Evo stent showed superior results in suppressing late proliferation compared to conventional DES. The Cre8Evo stent has been found to be safe and effective in clinical studies, and it has a superior effect in the clinical course of diabetic patients compared to other stents. The purpose of the study is to evaluate the effectiveness and safety of the Cre8Evo stent in actual clinical practice, specifically comparing outcomes in patients with and without diabetes.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Efficacy and safety of polymer-free amphilimus-eluting stent in patients with and without diabetes mellitus: A prospective, multicenter observational study.
Lim S, Kim JH, Hong SJ, Cha JJ, et al · · 2025 · PMID 41212864 · DOI 10.1371/journal.pone.0336017
Verify or expand the search:
- PubMed search for NCT05759676
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Korea University Anam Hospital 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 NCT05759676 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Korea University Anam Hospital
- Last refreshed: 4 April 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/NCT05759676.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing