Dynamic Change of Coronary Artery Curvature (DC3)

Dynamic Change of Coronary Artery Curvature After Adaptive Remodeling

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: DynamX Bioadaptor

Detailed Description

Coronary artery disease (CAD) is the most common type of heart disease and the leading cause of death worldwide. Percutaneous coronary intervention and coronary artery bypass graft are the guideline suggested treatment. Drug-eluting stents (DES) is the guideline suggested treatment options. Percutaneous coronary intervention with DES provides not just acute luminal gains, but also good long-term patency and clinical outcomes. However, in-stent neoatherosclerosis, very late stent thrombosis, and endothelial dysfunction remained important long-term issues. In addition, metallic stent encages the vessel segment, limits its remodeling and vasomotor function. The original vessel geometry, curvature, tortuosity, and wall shear stress, which are associated with plaque formation are also changed permanently by stent implantation. Although bioresorbable scaffolds attempted to address these issues by providing structural support to the vessel early on, followed by resorption, randomized trials showed that, prior to their resorption, they were less safe and effective than contemporary DES. Since that, the novel DES, DynamX Bioadaptor, is designed to improve these limitations.

The novel DES, DynamX Bioadaptor, is designed to restore normal pulsatility and adaptive remodeling in blood vessels after stent implantation. It is a cobalt-chromium stent with a biodegradable polymer coating that releases novolimus. Segments of the stent are held together by the polymer coating, which is designed to be fully absorbed in 6 months. After degradation of polymer, the stent struts unlink and uncage the stented segment. Pilot study demonstrated vessel uncaging and restoration of cyclic pulsatility 12 months after DynamX Bioadaptor implantation. Adaptive remodeling 12 months after DynamX Bioadaptor implantation will restore flexibility and natural geometry of the stented vessel segment. Thus, the dynamic beat-to-beat (cardiac cycle) changes of curvature and tortuosity will be more pronounced in the DynamX Bioadaptor group compared with that in the permanent metallic Elixir DESyne DES group. The DynamX Bioadaptor can potentially restore the vessel geometry and improve outcomes. The present randomized control study is designed to investigate the differences of dynamic coronary artery geometry changes after DynamX Bioadaptor and permanent metallic DES implantation, using coronary computed tomography angiography (CCTA) as an evaluation tool.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsien-Li Kao, MD; Phone Number: 62152 +886-2-23123456; Email: hsienli_kao@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DynamX Bioadaptor; 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; 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.; Other Names: DESyne Drug-eluting Stent
Active Comparator: DESyne Drug-eluting Stent; 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; 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.; Other Names: DESyne Drug-eluting Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The differences of vessel curvature change and tortuosity	The differences of vessel curvature change during systolic-diastolic phases, 12 months ± 2 weeks after DynamX Bioadaptor or Elixir DESyne DES implantation, measured by CCTA.	12 months ± 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The differences of vessel tortuosity change	The differences of vessel tortuosity change during systolic-diastolic phases, 12 months ± 2 weeks after DynamX Bioadaptor or Elixir DESyne DES implantation, measured by CCTA.	12 months ± 2 weeks
New plaque formation related in-stent/in-segment restenosis	In-stent/in-segment restenosis 12 months ± 2 weeks after DynamX Bioadaptor or Elixir DESyne DES implantation, measured by CCTA.	12 months ± 2 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 30, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Coronary artery disease; Drug eluting stent; Coronary intervention; Coronal curvature
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 202101142DIPA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The IPD data only could be shared after discuss with the principle investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No