Paclitaxel-Coated Balloon Versus Zotarolimus-Eluting Stent for Treatment of De Novo Coronary Artery Lesions (CAGE-FREE III)

  • End date
    Feb 1, 2025
  • participants needed
  • sponsor
    Xijing Hospital
Updated on 4 October 2022
myocardial infarction
percutaneous coronary intervention
antiplatelet therapy


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.

Condition De Novo Stenosis, Coronary Artery Disease, Percutaneous Coronary Intervention
Treatment Clopidogrel, Aspirin, Ticagrelor, Lepu Paclitaxel coated balloon, Resolute Integrity Zotarolimus eluting stents
Clinical Study IdentifierNCT05209412
SponsorXijing Hospital
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

18y ≤ age ≤ 80y
De-novo coronary artery lesions with indication for PCI
Target lesion diameter stenosis ≥ 70% (visual) or ≥ 50% (visual) with evidence of ischemia
Target lesion reference vessel diameter (2.5mm-4.0 mm), Length of a single target lesion ≤ 35mm; Total treated lesion length ≤ 60 mm
Vessels treated ≤ 2; only one DCB/DES is allowed for each target vessel
≤ 2 non-target lesions (non-TL) are allowed, and can not be in the same vessel as the target lesion (randomization should be implemented only after the successful treatment of all non-TL)
Patients who are able to complete the follow-up and compliant to the prescribed medication

Exclusion Criteria

Myocardial infarction (< 7 days)
Heavy thrombotic burden in target vessel
eGFR < 30ml/min or hemodialysis patients
Other cardiovascular and cerebrovascular percedures planned within 12 months after index PCI
Patients with contraindications to antiplatelet agents and anticoagulants; or bleeding tendency, history of active peptic ulcer, and stroke within 6 months
Life expectancy of less than 1 years
Patient is a woman who is pregnant or nursing
Known allergic to medications such as Aspirin, Heparin, antiplatelet drugs, paclitaxel, or contrast; patients with systemic lupus erythematosus or other systemic immune diseases
Chronic total occlusion lesion
Unprotected left main disease
Bifurcation lesion requiring 2 stents
Ostial lesions, distance from left main ≤ 2mm
Severe calcification or distortion
Arterial, venous or prosthetic grafts
In-stent stenosis requiring revascularization (defined as stenosis≥50% by visual or positive functional assessments in any vessel)
Myocardial bridging located at target lesions
Currently participating in another trial and not yet at its primary endpoint
Participants deemed unsutable to be enrolled by investigators for unable to comply to protocol or other reasons
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