Dynamic Change of Coronary Artery Curvature

NCT04936191 | Completed DMC

• 1 other identifier: 202101142DIPA
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Drug eluting stent; Coronary intervention; Coronal curvature

Outcome Measures

Primary Outcomes (1)

• The differences of vessel geometry

  The differences of vessel geometry during systolic-diastolic phases, 12 months ± 2 weeks after DynamX Bioadaptor or Elixir DESyne DES implantation, measured by CCTA.

  12 months ± 2 weeks

Secondary Outcomes (1)

• New plaque formation related in-stent/in-segment restenosis

  12 months ± 2 weeks

Study Arms (2)

DynamX Bioadaptor

EXPERIMENTAL

Patients were randomized during the percutaneous coronary intervention before stent implantation and assigned to the study arm using an electronic spreadsheet indicating the group assignment by random numbers. The patients will be 1:1 randomized to 2 groups: DynamX Bioadaptor and DESyne DES groups.

Device: DynamX Bioadaptor

DESyne Drug-eluting Stent

ACTIVE COMPARATOR

Patients were randomized during the percutaneous coronary intervention before stent implantation and assigned to the study arm using an electronic spreadsheet indicating the group assignment by random numbers. The patients will be 1:1 randomized to 2 groups: DynamX Bioadaptor and DESyne DES groups.

Device: DynamX Bioadaptor

Interventions

DynamX Bioadaptor DEVICE

Patients received percutaneous coronary intervention in a similar way to a traditional DES. Patients first receive radial artery or femoral artery cannulation with anticoagulation during the intervention. All coronary angiograms are carefully measured by at least 2 orthographic views and performed under the same standard conditions. After adequate predilatation of the target lesion, the coronary stenting will be performed. All patients will receive a loading dose of acetylsalicylic acid and a P2Y12 inhibitor pre-procedure followed by dual antiplatelet therapy for at least 6 months.

Also known as: DESyne Drug-eluting Stent

DESyne Drug-eluting Stent; DynamX Bioadaptor

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient is unwilling to join this study.
• 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.
• 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.
• The left ventricular ejection fraction is ≤ 40%.
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Cheng-Hsuan Tsai

Taipei, Please Select:, 100225, Taiwan

Location

Related Publications (2)

• Verheye S, Vrolix M, Montorfano M, Zivelonghi C, Giannini F, Bedogni F, Dubois C, De Bruyne B, Costa RA, Chamie D, de Ribamar Costa J Jr, Kereiakes DJ, Abizaid AA, Colombo A. Twelve-month clinical and imaging outcomes of the uncaging coronary DynamX bioadaptor system. EuroIntervention. 2020 Dec 18;16(12):e974-e981. doi: 10.4244/EIJ-D-20-00763.

  PMID: 32894231 RESULT

• Tsai CH, Chu HH, Huang CC, Yeh CF, Chen YH, Lin MS, Ko TY, Chen CK, Huang YC, Chiang PY, Lee WJ, Kao HL. Dynamic Change of Coronary Artery Geometry After Bioadaptor Implantation: A Single-blind Randomized Controlled Trial. Circ Cardiovasc Interv. 2026 Jan 29:e016191. doi: 10.1161/CIRCINTERVENTIONS.125.016191. Online ahead of print.

  PMID: 41608781 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Hsien-Li Kao, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: June 23, 2021
• Study Start: November 18, 2022
• Primary Completion: November 21, 2023
• Study Completion: December 31, 2024
• Last Updated: January 7, 2025

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)