Acute Coronary SyndromesNCT02601404
REal World Advanced Experience of BioResorbable ScaffolD by SMart Angioplasty Research Team (SMART REWARD)
An observational study of Acute Coronary Syndromes, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Current drug-eluting stents (DES) has demonstrated excellent clinical outcomes in patients with coronary artery disease. However, a continued risk of clinical events even several years after the procedure is reported. Stent platform or polymer-associated inflammation may play a role. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- Bioresorbable scaffold (BRS)
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to Dec 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 1,000 patients derived from a population of Korean patients receiving PCI for coronary artery disease will be enrolled in the present registry. It is recommended that each enrolling investigator review the most recent instructions for use (IFU) of Absorb™ and assess the contraindications, warnings, and precaution sections for treating potential patients.
Who may be able to join
- Subject must be between 19 and 70 years old.
- Patients with a significant lesion in a de novo coronary artery: a percent diameter stenosis (DS) 50% with 1) a positive history of recurrent angina pectoris; (2) objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent); or (3) abnormal results of any invasive functional diagnostic test (eg, fractional flow reserve) or a percent DS ≥70% even in the absence of the above-mentioned ischemic signs or symptoms.
- Patients are scheduled for coronary intervention
- He/she or his/her legally authorized representative provides written informed consent
Who cannot join
- Experience of cardiopulmonary resuscitation
- Cardiogenic shock
- Expected survival less than 2 years
- Pregnancy or breast feeding
- Opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Cardiac and Vascular Center; Samsung Medical Center
Seoul, 135-710
Hyeon-Cheol Gwon, Professor, 82234103419, hc.gwon@samsung.com
About this study
Current drug-eluting stents (DES) has demonstrated excellent clinical outcomes in patients with coronary artery disease. However, a continued risk of clinical events even several years after the procedure is reported. Stent platform or polymer-associated inflammation may play a role.
Bioresorbable scaffold (BRS) is known to disappear 2 to 3 years after the implantation, which may result in the more favorable very long-term clinical outcomes compared with metallic stents. The initial clinical experiences of BRS in relatively simple lesion subsets were comparable to DESs.
BRS, however, is limited by the disadvantageous mechanical characteristics such as thick strut and the risk of fracture by overdilation. There is concern that BRS is less optimal for complex lesion subsets such as bifurcation lesions, calcified tortuous lesions, or diffuse long lesions. Real world registry is needed to test the feasibility and safety of BRS in these complex lesion subsets.
- Conditions
- Acute Coronary Syndromes
- Being tested
- Bioresorbable scaffold (BRS)
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioresorbable scaffold (BRS)Device
Also called Absorb™ (Abbott Vascular)
The implantation procedure of an Absorb™ is similar to a metallic stent.
| Study group | Role | What they receive |
|---|---|---|
| Bioresorbable Scaffold | Patients receiving percutaneous coronary intervention (PCI) for coronary artery disease using Absorb™(Abbott Vascular) Receives: Device: Bioresorbable scaffold (BRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac death
Target vessel failure (TVF) of cardiac death, myocardial infarction (MI) attributed to the target vessel, and target vessel revascularization (TVR)
Measured: 2 years
Secondary outcomes (7)
Device success
Successful delivery and deployment of the study scaffold at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable).
Measured: maximum of 7 days
Procedural success
Achievement of final in-scaffold residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat target lesion revascularization (TLR) during the hospital stay (maximum of 7 days).
Measured: maximum of 7 days
Target vessel failure (TVF)
cardiac death, target vessel MI, or TVR
Measured: 1, 3, and 5 years
Each component of Target vessel failure (TVF)
Cardiac death,Vascular death,Non-cardiovascular death,Myocardial Infarction (MI)
Measured: 1, 2, 3 and 5 years
Target lesion failure
Target lesion failure of cardiac death, MI attributed to the target vessel, and Target Lesion Revascularization(TLR). TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.
Measured: 1, 2, 3 and 5 years
Definite or probable stent thrombosis
Measured: 1, 2, 3 and 5 years
Periprocedural enzyme elevation
Measured: 1, 2, 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeon-Cheol Gwon, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601404
- Sponsor's protocol ID
- 2015-07-163
- Status last verified
- Mar 2017
- First submitted
- 5 Nov 2015
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee JM, Joh HS, Choi KH, Hong D, Park TK, Yang JH, Song YB, Choi JH, Choi SH, Jeong JO, Lee JY, Choi YJ, Chae JK, Hur SH, Bae JW, Oh JH, Chun KJ, Kim HJ, Cho BR, Shin D, Lee SH, Hwang D, Lee HJ, Jang HJ, Kim HK, Ha SJ, Shin ES, Doh JH, Hahn JY, Gwon HC; SMART-REWARD Investigators. Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice. J Korean Med Sci. 2023 Feb 6;38(5):e34. doi: 10.3346/jkms.2023.38.e34.
PubMed 36747363
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REal World Advanced Experience of BioResorbable ScaffolD by SMart Angioplasty Research Team (SMART REWARD)
- ClinicalTrials.gov ID
- NCT02601404
- Acronym / sponsor ID
- 2015-07-163
- Conditions
- Acute Coronary Syndromes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Nov 2015 (estimated)
- 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.
Current drug-eluting stents (DES) has demonstrated excellent clinical outcomes in patients with coronary artery disease. However, a continued risk of clinical events even several years after the procedure is reported. Stent platform or polymer-associated inflammation may play a role.
Bioresorbable scaffold (BRS) is known to disappear 2 to 3 years after the implantation, which may result in the more favorable very long-term clinical outcomes compared with metallic stents. The initial clinical experiences of BRS in relatively simple lesion subsets were comparable to DESs.
BRS, however, is limited by the disadvantageous mechanical characteristics such as thick strut and the risk of fracture by overdilation. There is concern that BRS is less optimal for complex lesion subsets such as bifurcation lesions, calcified tortuous lesions, or diffuse long lesions. Real world registry is needed to test the feasibility and safety of BRS in these complex lesion subsets.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bioresorbable Scaffold | – | Device: Bioresorbable scaffold (BRS)Patients receiving percutaneous coronary intervention (PCI) for coronary artery disease using Absorb™(Abbott Vascular) |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 1,000 patients derived from a population of Korean patients receiving PCI for coronary artery disease will be enrolled in the present registry. It is recommended that each enrolling investigator review the most recent instructions for use (IFU) of Absorb™ and assess the contraindications, warnings, and precaution sections for treating potential patients.
Key inclusion criteria (4 listed)
- Subject must be between 19 and 70 years old.
- Patients with a significant lesion in a de novo coronary artery: a percent diameter stenosis (DS) 50% with 1) a positive history of recurrent angina pectoris; (2) objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent); or (3) abnormal results of any invasive functional diagnostic test (eg, fractional flow reserve) or a percent DS ≥70% even in the absence of the above-mentioned ischemic signs or symptoms.
- Patients are scheduled for coronary intervention
- He/she or his/her legally authorized representative provides written informed consent
Key exclusion criteria (5 listed)
- Experience of cardiopulmonary resuscitation
- Cardiogenic shock
- Expected survival less than 2 years
- Pregnancy or breast feeding
- Opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
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 |
|---|---|---|
| Bioresorbable scaffold (BRS)Also: Absorb™ (Abbott Vascular)The implantation procedure of an Absorb™ is similar to a metallic stent. | Device | Bioresorbable Scaffold |
Primary outcome
cardiac death
Time frame: 2 years
Target vessel failure (TVF) of cardiac death, myocardial infarction (MI) attributed to the target vessel, and target vessel revascularization (TVR)
7 secondary outcomes
Device success
Time frame: maximum of 7 days
Procedural success
Time frame: maximum of 7 days
Target vessel failure (TVF)
Time frame: 1, 3, and 5 years
Each component of Target vessel failure (TVF)
Time frame: 1, 2, 3 and 5 years
Target lesion failure
Time frame: 1, 2, 3 and 5 years
Definite or probable stent thrombosis
Time frame: 1, 2, 3 and 5 years
Periprocedural enzyme elevation
Time frame: 1, 2, 3 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Derived from this study: PubMed 36747363Lee JM, Joh HS, Choi KH, Hong D, Park TK, Yang JH, Song YB, Choi JH, Choi SH, Jeong JO, Lee JY, Choi YJ, Chae JK, Hur SH, Bae JW, Oh JH, Chun KJ, Kim HJ, Cho BR, Shin D, Lee SH, Hwang D, Lee HJ, Jang HJ, Kim HK, Ha SJ, Shin ES, Doh JH, Hahn JY, Gwon HC; SMART-REWARD Investigators. Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice. J Korean Med Sci. 2023 Feb 6;38(5):e34. doi: 10.3346/jkms.2023.38.e34.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes, run by Samsung Medical Center at 1 site in South Korea.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Mar 2017. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HyeonCheol Gwon, MD,Ph.D. (2-3410-3418 ext. 82, hc.gwon@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac death (time frame: 2 years). 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 NCT02601404, which also lists 1 linked publication.
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 3 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.