NCT05209412: CAGE-FREEIII

Paclitaxel-Coated Balloon Versus Zotarolimus-Eluting Stent for Treatment of De Novo Coronary Artery Lesions

Status unknown NA Last updated 24 January 2024

What this trial tests

NA trial testing Lepu Paclitaxel coated balloon in De Novo Stenosis in 370 participants. Status unknown.

Timeline

1 February 2022

Primary endpoint
1 February 2024

1 February 2025

Quick facts

Lead sponsor	Xijing Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	370
Start date	1 February 2022
Primary completion	1 February 2024
Estimated completion	1 February 2025
Sites	1 location across China

Drugs / interventions tested

• Lepu Paclitaxel coated balloon
• Resolute Integrity Zotarolimus eluting stents
• Aspirin — full drug profile →
• Ticagrelor (ticagrelor) — full drug profile →
• Clopidogrel (clopidogrel) — full drug profile →

Conditions studied

• De Novo Stenosis — all drugs for De Novo Stenosis →
• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• Percutaneous Coronary Intervention — all drugs for Percutaneous Coronary Intervention →

Sponsor

Xijing Hospital

Who can join

Adults 18 to 80, any sex, with De Novo Stenosis or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Coronary restenosis has been one of the main reasons affecting the prognosis of patients with coronary artery disease (CAD) after percutaneous coronary intervention (PCI). With drug-eluting stents (DES), which elutes an antiproliferative drug to the vessel wall and reduces the restenosis rate; however, the incidence of restenosis is still about 10%. The late stent thrombosis and restenosis, with a hazard of nearly 2% per year after implantation, remained a concern and motivated the development of drug-coated balloons (DCB).

DCB angioplasty has the following advantages compared with DES implantation: Firstly, the drug in DCB is uniformly distributed and released; whereas the drug release of DES via stent platform is uneven -85% of the vascular wall is not covered by the stent strut. Secondly, there is no alloy in the vessel after DCB angioplasty, while the coronary stent platform and polymer might cause temporal or persistent inflammatory response leading to intimal hyperplasia. Finally, there is no metal cage restraining vessel motion after DCB, the physiological function of coronary arteries would be maintained.

Studies with the strategy of DCB angioplasty with bailout stenting have demonstrated safety and efficacy for the small-vessel disease. The application of DCB in large vessels with de novo lesions is still to be investigated. The DEBUT study showed that in high bleeding risk patients aimed using only 1-month DAPT, DCB was superior to BMS in terms of MACE \[MACE (cardiovascular mortality, nonfatal myocardial infarction or revascularization of ischemia-reperfusion target lesions)\] at 9-month follow-up.

However, there is still a lack of evidence comparing the DCB versus DES in large vessels with de novo lesions. The current study aims to investigate if in patients undergoing PCI for de novo stenoses in large vessels, DCB is non-inferior to DES.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immediate and follow-up outcomes of drug-coated balloon angioplasty in de novo long lesions on large coronary arteries.
   Leone PP, Oliva A, Regazzoli D, Gitto M, et al · · 2023 · cited 23× · PMID 37670668 · DOI 10.4244/eij-d-23-00502
2. Drug-Coated Balloons: Recent Evidence and Upcoming Novelties.
   Shahrori ZMF, Frazzetto M, Mahmud SH, Alghwyeen W, et al · · 2025 · cited 6× · PMID 40422965 · DOI 10.3390/jcdd12050194
3. Exploring New Avenues for De Novo Coronary Artery Disease: Next Steps Forward With Drug-Coated Balloons.
   Kang DO, Kim SW, Jeong YH. · · 2024 · cited 2× · PMID 39101108 · DOI 10.1016/j.jacasi.2024.05.006
4. The longest way round is the shortest way home: drug-coated balloons for long lesions in large coronary arteries.
   Gonzalo N, Shabbir A. · · 2023 · cited 1× · PMID 38105718 · DOI 10.4244/eij-e-23-00043
5. Drug-coated balloons in complex large-vessel coronary artery disease: a comprehensive review of current evidence and future perspectives.
   Gitto M, Gabrielli A, Leone PP, Sanz-Sanchez J, et al · · 2026 · PMID 41815903 · DOI 10.3389/fcvm.2026.1731952
6. Contemporary Percutaneous Coronary Intervention in Diabetic Patients.
   Tartaglia F, Filiberti G, Bernardini V, Gitto M, et al · · 2025 · PMID 41524061 · DOI 10.31083/rcm44861