De Novo StenosisREC-CAGEFREE ⅣNCT07022587
Bioresorbable Sirolimus-eluting scaffold in de Novo Coronary Artery Lesions
A study testing Sirolimus-eluting bioresorbable scaffolds and Sirolimus-eluting stents in people with De Novo Stenosis and Coronary Artery Disease, run by Xijing Hospital at 1 site in China.
Trial summary
Bioresorbable scaffold (BRS) was designed aiming to avoid the late adverse events associated with permanent metallic stents by providing temporary support to the vessel wall and promoting vessel remodeling, plaque reduction, and restoring vasomotion after its full absorption. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- De Novo Stenosis, Coronary Artery Disease
- What is being tested?
- Sirolimus-eluting bioresorbable scaffolds and Sirolimus-eluting stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2025to 20 Dec 2073
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical inclusion criteria
- Patients with an indication for PCI due to acute or chronic coronary syndrome
- Patients who understand the study's objectives, voluntarily participate, sign the informed consent form, and are willing to undergo regular follow-up
- Angiographic inclusion criteria
- De novo lesion(s)
- Target vessel diameter of ≥ 2.5 mm to ≤ 4.00 mm, target lesion length ≤ 25 mm (visual estimation)
Show all 13Show fewer
- Target lesion is NOT
- Severely calcified
- In-stent restenosis
- Diffused lesion requiring stent overlapping or more than one stent
- Located in the left main, aorto-ostial, proximal LAD/LCX/RCA involving vessel ostia (stent coverage required within 3 mm of vessel ostia), surgical graft, myocardial bridge, or chronic total occlusion
- Bifurcation requiring two stents or involving a side branch that is ≥ 2.5 mm in diameter
- Located in the target vessel with severe tortuosity
Who cannot join
- Age < 18 years, or > 75 years
- Patient is a woman who is pregnant or nursing
- Patients who have received any stent implantation in the target vessel within one year
- Patients required long-term oral anticoagulation
- Known non-adherence to antiplatelet therapy or not suitable for long-term antiplatelet therapy due to high bleeding risk
- Patients who are allergic to heparin, poly L-lactic acid (PLLA), sirolimus, antiplatelet drugs, or contrast
Show all 9Show fewer
- Currently participating in another trial and not yet at its primary endpoint
- Patients whose life expectancy is less than 3 years
- Cardiogenic shock
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shannxi, 710032
Chao Gao, charleygao@qq.com
About this study
Official title: A Bioresorbable Sirolimus-eluting scaffold Versus a Metallic Sirolimus-eluting Stent for the Treatment of de Novo Coronary Artery Lesions: a Randomized, Open-label, Non-inferiority Trial
Bioresorbable scaffold (BRS) was designed aiming to avoid the late adverse events associated with permanent metallic stents by providing temporary support to the vessel wall and promoting vessel remodeling, plaque reduction, and restoring vasomotion after its full absorption. As the first FDA-approved BRS, ABSORB BRS was associated with a significantly higher risk of late scaffold thrombosis compared with everolimus-eluting stent (EES). As a result, the ESC-EAPCI task force recommended that the current ABSORB BRS should not be preferred over conventional DES in clinical practice. To solve this dilemma, improved scaffold technology and optimal implantation techniques are necessary.
The latest generation Firesorb BRS is a PLLA backbone scaffold system abluminally coated with poly(D, L-lactide) mixed with sirolimus using highly accurate and precise point spraying techniques. Compared to the ABSORB BRS, Firesorb features a thinner stent thickness (100-125 μm) while maintaining sufficient radial support, enabling faster degradation and a shorter duration of presence in the coronary. Additionally, inspired by the design of the Firehawk DES, its unique spot-coating process applies a single-sided coating layer exclusively to the stent's outer surface, enabling targeted drug release. Preclinical trials have demonstrated favorable performance for Firesorb, culminating in its approval by the National Medical Products Administration (NMPA) in 2024.
Against these backgrounds, we have designed this trial to investigate whether the Firesorb BRS is non-inferior to the drug-eluting stent in terms of the Device-Oriented Composite Endpoint (DoCE) in patients undergoing percutaneous coronary intervention for de novo lesions.
- Conditions
- De Novo Stenosis, Coronary Artery Disease
- Being tested
- Sirolimus-eluting bioresorbable scaffolds, Sirolimus-eluting stents
- Keywords
- bioresorbable vascular scaffold, drug-eluting stent, de novo stenosis, percutaneous coronary intervention
- 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.
Sirolimus-eluting bioresorbable scaffoldsDevice
The Firesorb BRS (MicroPort Medical, Shanghai, China) is a balloon-expandable scaffold with a highly crystallized PLLA backbone, abluminally coated with a poly(D, L-lactide) (PDLLA) matrix incorporating sirolimus (4 μg/mm) through highly accurate and precise point spraying techniques. The scaffold thickness is 100 μm for devices with diameters of 2.5 and 2.75 mm, and 125 μm for those ranging from 3.0 to 4.0 mm in diameter. There are two radiopaque markers at each end of the scaffold, which can identify the position of the stent under X-ray monitoring and help to accurately locate the scaffold.
Sirolimus-eluting stentsDevice
The Firehawk™ stent (MicroPort Medical, Shanghai, China) is a third-generation balloon-expandable L605 cobalt chromium stent with abluminal grooves containing a biodegradable polymer, which provides controlled release of the anti-proliferative medicinal substance sirolimus. The polymer is biodegradable, leaving only the metallic stent as a permanent implant. The stent is mounted on a rapid exchange delivery catheter system. The unique abluminal grooves are scored at the outer surface of the struts (total strut thickness: 86 μm), with an average sirolimus dosage of 3 µg/mm stent lengths.
| Study group | Role | What they receive |
|---|---|---|
| Bioresorbable scaffold (BRS) | Experimental | Not described Receives: Device: Sirolimus-eluting bioresorbable scaffolds |
| Drug-eluting stents (DES) | Active comparator | Not described Receives: Device: Sirolimus-eluting stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative event rate of Device-oriented Composite Endpoint (DoCE)
DoCE is a composite clinical endpoint of cardiovascular death, target vessel myocardial infarction (TV-MI), and clinically and physiologically indicated target lesion revascularization (CPI-TLR).
Measured: 36 months
Secondary outcomes (13)
Cumulative event rate of Device-oriented Composite Endpoint (DoCE)
Rates of the DoCE beside the time point of primary endpoint
Measured: 1, 12, and 60 months
Cumulative event rate of Patient-oriented composite endpoint (PoCE)
PoCE is defined as a composite endpoint including all-cause death, stroke, myocardial infarction, and revascularization
Measured: 1, 12, 36, and 60 months
Cumulative event rate of Target vessel failure (TVF)
TVF is defined as a composite endpoint including cardiovascular death, TV-MI and clinically and physiologically target vessel revascularization
Measured: 1, 12, 36, and 60 months
Cumulative event rate of All-cause death
Individual components of PoCE
Measured: 1, 12, 36, and 60 months
Cumulative event rate of Cardiovascular death
Individual components of the DoCE
Measured: 1, 12, 36, and 60 months
Cumulative event rate of Stroke
Individual components of PoCE
Measured: 1, 12, 36, and 60 months
Cumulative event rate of Myocardial infarction
Individual components of PoCE
Measured: 1, 12, 36, and 60 months
Cumulative event rate of Target vessel myocardial infarction (TV-MI)
Individual components of DoCE
Measured: 1, 12, 36, and 60 months
Cumulative event rate of Revascularization
Individual components of PoCE
Measured: 1, 12, 36, and 60 months
Cumulative event rate of Clinically and physiologically indicated target vessel revascularization
Individual components of TVF
Measured: 1, 12, 36, and 60 months
Cumulative event rate of Clinically and physiologically indicated target lesion revascularization (CPI-TLR)
Individual components of the DoCE
Measured: 1, 12, 36, and 60 months
Cumulative event rate of Definite/Probable scaffold/stent thrombosis
According to ARC-2 definitions
Measured: 1, 12, 36, and 60 months
Cumulative event rate of BARC defined type 3 or 5 bleeding events
Measured: 1, 12, 36, and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start20 Dec 2025
- Primary completion20 Dec 2030 (estimated)
- Study completion20 Dec 2073 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for De Novo StenosisStudies of the same condition, open and under way.
- More trials run by Xijing 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Tao, MD, PhD, Xijing Hospital
- Investigators
- Ling Tao, M.D., Ph.D., Study chair, Xijing HospitalPatrick Serruys, M.D., Ph.D., Study chair, National University of Ireland, Galway, IrelandYoshinobu Onuma, M.D., Ph.D., Study chair, National University of Ireland, Galway, IrelandChao Gao, M.D., Ph.D., Study chair, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022587
- Sponsor's protocol ID
- KY20252116-C-1
- Acronym
- REC-CAGEFREE Ⅳ
- Status last verified
- Feb 2026
- First submitted
- 6 Jun 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioresorbable Sirolimus-eluting scaffold Versus a Metallic Sirolimus-eluting Stent for the Treatment of de Novo Coronary Artery Lesions: a Randomized, Open-label, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT07022587
- Acronym / sponsor ID
- REC-CAGEFREE Ⅳ / KY20252116-C-1
- Conditions
- De Novo Stenosis, Coronary Artery Disease
- Keywords
- bioresorbable vascular scaffold, drug-eluting stent, de novo stenosis, percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 20 Dec 2030 (estimated)
- Study completion
- 20 Dec 2073 (estimated)
- First posted
- 15 Jun 2025 (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.
Bioresorbable scaffold (BRS) was designed aiming to avoid the late adverse events associated with permanent metallic stents by providing temporary support to the vessel wall and promoting vessel remodeling, plaque reduction, and restoring vasomotion after its full absorption. As the first FDA-approved BRS, ABSORB BRS was associated with a significantly higher risk of late scaffold thrombosis compared with everolimus-eluting stent (EES). As a result, the ESC-EAPCI task force recommended that the current ABSORB BRS should not be preferred over conventional DES in clinical practice. To solve this dilemma, improved scaffold technology and optimal implantation techniques are necessary.
The latest generation Firesorb BRS is a PLLA backbone scaffold system abluminally coated with poly(D, L-lactide) mixed with sirolimus using highly accurate and precise point spraying techniques. Compared to the ABSORB BRS, Firesorb features a thinner stent thickness (100-125 μm) while maintaining sufficient radial support, enabling faster degradation and a shorter duration of presence in the coronary. Additionally, inspired by the design of the Firehawk DES, its unique spot-coating process applies a single-sided coating layer exclusively to the stent's outer surface, enabling targeted drug release. Preclinical trials have demonstrated favorable performance for Firesorb, culminating in its approval by the National Medical Products Administration (NMPA) in 2024.
Against these backgrounds, we have designed this trial to investigate whether the Firesorb BRS is non-inferior to the drug-eluting stent in terms of the Device-Oriented Composite Endpoint (DoCE) in patients undergoing percutaneous coronary intervention for de novo lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioresorbable scaffold (BRS) | Experimental | Device: Sirolimus-eluting bioresorbable scaffolds |
| Drug-eluting stents (DES) | Active comparator | Device: Sirolimus-eluting stents |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Clinical inclusion criteria
- Patients with an indication for PCI due to acute or chronic coronary syndrome
- Patients who understand the study's objectives, voluntarily participate, sign the informed consent form, and are willing to undergo regular follow-up
- Angiographic inclusion criteria
- De novo lesion(s)
Key exclusion criteria (9 listed)
- Age < 18 years, or > 75 years
- Patient is a woman who is pregnant or nursing
- Patients who have received any stent implantation in the target vessel within one year
- Patients required long-term oral anticoagulation
- Known non-adherence to antiplatelet therapy or not suitable for long-term antiplatelet therapy due to high bleeding risk
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 |
|---|---|---|
| Sirolimus-eluting bioresorbable scaffoldsThe Firesorb BRS (MicroPort Medical, Shanghai, China) is a balloon-expandable scaffold with a highly crystallized PLLA backbone, abluminally coated with a poly(D, L-lactide) (PDLLA) matrix incorporating sirolimus (4 μg/mm) through highly accurate and precise point spraying techniques. The scaffold thickness is 100 μm for devices with diameters of 2.5 and 2.75 mm, and 125 μm for those ranging from 3.0 to 4.0 mm in diameter. There are two radiopaque markers at each end of the scaffold, which can identify the position of the stent under X-ray monitoring and help to accurately locate the scaffold. | Device | Bioresorbable scaffold (BRS) |
| Sirolimus-eluting stentsThe Firehawk™ stent (MicroPort Medical, Shanghai, China) is a third-generation balloon-expandable L605 cobalt chromium stent with abluminal grooves containing a biodegradable polymer, which provides controlled release of the anti-proliferative medicinal substance sirolimus. The polymer is biodegradable, leaving only the metallic stent as a permanent implant. The stent is mounted on a rapid exchange delivery catheter system. The unique abluminal grooves are scored at the outer surface of the struts (total strut thickness: 86 μm), with an average sirolimus dosage of 3 µg/mm stent lengths. | Device | Drug-eluting stents (DES) |
Primary outcome
Cumulative event rate of Device-oriented Composite Endpoint (DoCE)
Time frame: 36 months
DoCE is a composite clinical endpoint of cardiovascular death, target vessel myocardial infarction (TV-MI), and clinically and physiologically indicated target lesion revascularization (CPI-TLR).
13 secondary outcomes
Cumulative event rate of Device-oriented Composite Endpoint (DoCE)
Time frame: 1, 12, and 60 months
Cumulative event rate of Patient-oriented composite endpoint (PoCE)
Time frame: 1, 12, 36, and 60 months
Cumulative event rate of Target vessel failure (TVF)
Time frame: 1, 12, 36, and 60 months
Cumulative event rate of All-cause death
Time frame: 1, 12, 36, and 60 months
Cumulative event rate of Cardiovascular death
Time frame: 1, 12, 36, and 60 months
Cumulative event rate of Stroke
Time frame: 1, 12, 36, and 60 months
Cumulative event rate of Myocardial infarction
Time frame: 1, 12, 36, and 60 months
Cumulative event rate of Target vessel myocardial infarction (TV-MI)
Time frame: 1, 12, 36, and 60 months
Cumulative event rate of Revascularization
Time frame: 1, 12, 36, and 60 months
Cumulative event rate of Clinically and physiologically indicated target vessel revascularization
Time frame: 1, 12, 36, and 60 months
Cumulative event rate of Clinically and physiologically indicated target lesion revascularization (CPI-TLR)
Time frame: 1, 12, 36, and 60 months
Cumulative event rate of Definite/Probable scaffold/stent thrombosis
Time frame: 1, 12, 36, and 60 months
Cumulative event rate of BARC defined type 3 or 5 bleeding events
Time frame: 1, 12, 36, and 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Ling Tao, M.D., Ph.D. study chair
Xijing Hospital
Patrick Serruys, M.D., Ph.D. study chair
National University of Ireland, Galway, Ireland
Yoshinobu Onuma, M.D., Ph.D. study chair
National University of Ireland, Galway, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sirolimus-eluting bioresorbable scaffolds and Sirolimus-eluting stents in people with De Novo Stenosis and Coronary Artery Disease, run by Xijing Hospital at 1 site in China.
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 13 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Gao, M.D., Ph.D. (+86-18629551066, woshigaochao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative event rate of Device-oriented Composite Endpoint (DoCE) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.