Coronary Artery DiseaseDC3NCT04936191
Dynamic Change of Coronary Artery Curvature
A study testing DynamX Bioadaptor in people with Coronary Artery Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- DynamX Bioadaptor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Nov 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- DynamX Bioadaptor
- Keywords
- Coronary artery disease, Drug eluting stent, Coronary intervention, Coronal curvature
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DynamX BioadaptorDevice
Also called DESyne Drug-eluting Stent
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: DynamX Bioadaptor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months ± 2 weeks
Secondary outcomes (1)
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.
Measured: 12 months ± 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start18 Nov 2022
- Primary completion21 Nov 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsien-Li Kao, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936191
- Sponsor's protocol ID
- 202101142DIPA
- Acronym
- DC3
- Status last verified
- Jul 2022
- First submitted
- 30 May 2021
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD data only could be shared after discuss with the principle investigator.
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.
PubMed 32894231Tsai 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 Feb;19(2):e016191. doi: 10.1161/CIRCINTERVENTIONS.125.016191. Epub 2026 Jan 29.
PubMed 41608781
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Change of Coronary Artery Curvature After Adaptive Remodeling
- ClinicalTrials.gov ID
- NCT04936191
- Acronym / sponsor ID
- DC3 / 202101142DIPA
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Drug eluting stent, Coronary intervention, Coronal curvature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DynamX Bioadaptor | Experimental | Device: DynamX BioadaptorPatients 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. |
| DESyne Drug-eluting Stent | Active comparator | Device: DynamX BioadaptorPatients 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DynamX BioadaptorAlso: DESyne Drug-eluting StentPatients 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. | Device | DESyne Drug-eluting Stent, DynamX Bioadaptor |
Primary outcome
The differences of vessel geometry
Time frame: 12 months ± 2 weeks
The differences of vessel geometry during systolic-diastolic phases, 12 months ± 2 weeks after DynamX Bioadaptor or Elixir DESyne DES implantation, measured by CCTA.
1 secondary outcome
New plaque formation related in-stent/in-segment restenosis
Time frame: 12 months ± 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Results publication: PubMed 32894231Verheye 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.
- Derived from this study: PubMed 41608781Tsai 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 Feb;19(2):e016191. doi: 10.1161/CIRCINTERVENTIONS.125.016191. Epub 2026 Jan 29.
- Individual participant dataSharing planned: No. The IPD data only could be shared after discuss with the principle investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsien-Li Kao, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DynamX Bioadaptor in people with Coronary Artery Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The differences of vessel geometry (time frame: 12 months ± 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04936191, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.