STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) Trial

Study acronym: STENTLESS
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 4 of 12 entries
  2. Primary completion date: Dec 30, 2025 to Feb 15, 2027v3 Show 7 more changesShow less
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 30, 2025 to Feb 15, 2031
    • Interventions: Drug-coated balloon (Bingo© [Paclitaxel-coated Balloon], Yinyi Ltd., China) (Device), Drug-eluting stent (Device) to Drug-coated balloon (Commercially available Paclitaxel-coated Balloon, China) (Device), Drug-eluting stent (Device)
    • Eligibility criteria shortened, about 126 words
    • Secondary endpoints revised (12)
    • Site details revised
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 1, 2023 to Oct 15, 2023
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multicenter, open-label, randomized controlled study meant to compare the safety and efficacy of scheduled drug-coated balloon (DCB) and conventional drug-eluting stent (DES) strategy in the treatment of de novo lesions of large coronary vessel with diameter larger than 2.75 mm. The trial was designed to provide high-quality evidence for expanding the clinical indications of DCB, and to explore a better way for coronary intervention based on DCB.
Trial Details
NCT Number NCT06084000
Lead Sponsor China National Center for Cardiovascular Diseases
Conditions
(from sponsor)		 Drug-coated Balloon, Drug-eluting Stent, De Novo Stenosis
Enrollment 2,700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov