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NCT04936191Completed

Dynamic Change of Coronary Artery Curvature

Dynamic Change of Coronary Artery Curvature After Adaptive Remodeling

Source: ClinicalTrials.gov · Last updated 7 Jan 2025

Brief summary (registry, in English)

The novolimus-eluting DynamX bioadaptor system is composed of 71 µm cobalt-chromium sinusoidal rings connected to each other axially by three S-links Each ring contains three uncaging elements that are positioned at equal distance in low stress regions of struts oriented in a helical configuration along the length of the bioadaptor which remain intact after uncaging. The uncaging elements consist of three separable junctions per ring held together by a 6 µm polymer coating that is resorbed over six months, allowing uncaging of the vessel and adaptive remodeling. Previous study showed the DynamX biodaptor is safe and effective treating in de novo coronary lesion. It also increased of vessel and device area while maintain in the mean lumen area after one year follow-up. However, the unchanging effect of Dynamx bioadaptor on coronary geometry change remained unknown. The present randomized control study is designed to investigate the differences of dynamic coronary artery geometry changes evaluated by coronary computed tomography angiography after DynamX Bioadaptor and permanent metallic DES implantation.

Status (registry)
Completed
Study type
Interventional
Enrollment
48 (actual)
First submitted
30 May 2021
Start date
18 Nov 2022
Primary completion date
21 Nov 2023
Lead sponsor
National Taiwan University Hospital
NCT number
NCT04936191

What you commit to

  • Study type: Interventional
  • Participants enrolled: 48
  • From 18 Nov 2022 to the primary completion date, 21 Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • Patients have end-stage renal disease under dialysis, chronic kidney disease (serum creatine \> 1.5 mg/dL), symptomatic heart failure, active cancer, high bleeding risk, ST elevation myocardial infarction or hemodynamic unstable non-ST elevation myocardial infarction.
  • The left ventricular ejection fraction is ≤ 40%.

Other

  • Patient is unwilling to join this study.
  • Coronary lesion with following features: heavily calcification, ostial lesion, lesions requiring post-stenting side branch dilatation and lesions required more than one stent to treat.
  • No scheduled operation within six months after the coronary stenting is allowed unless continuous dual antiplatelet use is acceptable.
  • Patients are unsuitable or unable to receive CCTA.
  • Pregnant women or women with breast feeding or suitable pregnant women without contraception during the study period.
  • Patient is currently participating another interventional trial.

Who the study is looking for

  • Patient is ≥ 20 years old.
  • Written informed consent can be obtained.
  • The enrolled coronary vessel only has one target coronary lesion required stenting.
  • The target coronary lesion is 50 to 100% stenosis and stenting is required.
  • Coronary artery de novo lesion requiring implantation of a single drug eluting stent with length ≥ 32 mm.
  • Patients are able to tolerate dual antiplatelets for at least six months.

Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cheng-Hsuan Tsai
Coordinator of this site? Confirm its status		TaipeiTaiwanUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.