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Coronary Artery DiseaseIRONMAN-IINCT05206084

A Clinical Investigation to Evaluate the Safety and Efficacy of IBS in Patients With Coronary Artery Disease

A study testing Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS) and Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System in people with Coronary Artery Disease, run by Biotyx Medical (Shenzhen) Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A prospective, multi-center, single-blinded, randomized trial to assess the safety and efficacy of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS) in treating patients with coronary artery disease compared to the Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS) and Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
518 participants
Where
1 siteChina
Study dates
10 Mar 2022to Jan 2028
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

  • Patient must between 18 and 75 years old, male or non-pregnant female.
  • Patient must have evidence of myocardial ischemia (e.g., stable, unstable angina, silent myocardial ischemia, or acute myocardial infarction>1 week) suitable for elective PCI.
  • One or two de novo target lesions each located in a different epicardial vessel.
  • If there is one target lesion, another non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful result prior to randomization of the target lesion.
  • If two target lesions are present, they must be present in different epicardial vessels and both satisfy the angiographic eligibility criteria.
  • The definition of epicardial vessels means the left anterior descending artery (LAD), the left circumflex artery (LCX), and the right coronary artery (RCA) and their branches. Thus, for example, the subject must not have lesions requiring treatment in both the LAD and a diagonal branch.
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  • Lesion(s) must have a visually estimated length of ≤33mm, diameter between range of 2.5-4.0mm, and each lesion can be completely covered by a stent.
  • Lesion(s) must have a visually estimated diameter stenosis of ≥70% (or ≥50% and have evidence of myocardial ischemia in this location) with a TIMI flow of ≥1.
  • Patient can understand the study purpose, voluntarily participate in the study, sign the informed consent, and willing to undergo protocol-required invasive angiographic follow-ups.

Who cannot join

  • General Exclusion Criteria
  • Patient had an acute myocardial infarction (AMI) or CK and CK-MB have not returned to within normal limits after myocardial infarction within 7 days of the index procedure.
  • Patient has implanted stent in the target vessel within 1 year of the index procedure, or is scheduled to undergo re-intervention in the future 6 months.
  • Patient with a history of coronary artery bypass (coronary artery bypass grafting).
  • Patient with contraindications on coronary artery bypass graft surgery.
  • Patient with severe heart failure (NYHA class ≥III) or left ventricular ejection fraction<40% (by echocardiography or contrast left ventriculography).
Show all 45Show fewer
  • Patient with known renal insufficiency: serum creatinine > 2.0 mg/dl or 177 μmol/L, or/and patient on dialysis.
  • Patient with known hepatic insufficiency: ALT, AST >3 times the upper limit of normal.
  • Patient had an ischemic stroke within 6 months or transient ischemic neurological attack (TIA) within 3 months before the index procedure, or has tendency of hypercoagulation as per investigator judgement or laboratory test.
  • Patient with bleeding diathesis, active gastrointestinal ulcers, history of cerebral hemorrhage or subarachnoid hemorrhage, contraindications on antiplatelet agents and anticoagulant therapy, and unable to undergoing antithrombotic therapy.
  • Patient with known allergy to aspirin, clopidogrel, heparin, contrast agent, PDLLA, sirolimus and metal (iron, zinc etc).
  • Patient with a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc.
  • Patient with life expectancy <2 years.
  • Patient is already participating in another drug or medical device clinical trial that has not yet reached its primary endpoint.
  • Patient with poor compliance and cannot comply with the protocol requirement as per investigator judgement.
  • Subject has received a heart transplant.
  • Patient with unstable arrhythmia, such as high-risk ventricular premature beat and ventricular tachycardia.
  • Patient requires chemotherapy for malignancy.
  • Patient with known immunosuppressive or autoimmune disease, and is receiving or scheduled to receive immunosuppressant therapy.
  • Patient is receiving or scheduled to receive chronic anticoagulation therapy such as aspirin and warfarin, etc.
  • Patient is scheduled to receive a surgery that requires to stop antiplatelet drugs such as heparin and clopidogrel within 6 months after the index procedure.
  • Patient has a platelet count <100x10^9/L or >700 x10^9/L, a white blood cell count of <3 x10^9/L during the screening period.
  • Patient with diffuse peripheral vascular disease, and cannot use 6F catheter.
  • Patient with prior valvular surgery.
  • Angiographic exclusion criteria
  • Chronic total occlusion (TIMI flow of 0 before the index procedure).
  • Target lesion is located in left main.
  • Aorto-ostial lesion (within 3 mm of the ostium).
  • Target lesion involving a bifurcation lesion with side branch ≥2.5 mm in diameter (the ostium of side branch has restenosis ≥40% or require balloon pre-dilatation).
  • Visible thrombus in target vessels.
  • Severe triple vessels lesions and all require revascularization.
  • Severe calcified or distorted lesions which unable to predilate, not suitable for stent delivery and expansion, impair delivery including:
  • Extreme angulation (≥ 90°) proximal to or within the target lesion
  • Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion
  • Moderate or heavy calcification proximal to or within the target lesion
  • In-stent restenosis target lesion.
  • Target lesion involves a myocardial bridge.
  • The investigational stent would need to cross the previously implanted stent to reach the target lesion.
  • Target lesion which prevents complete balloon pre-dilatation, defined as full balloon expansion with the following outcomes:
  • Residual diameter stenosis (DS%) is < 40% (per visual estimation), ≤ 20% is strongly recommended.
  • TIMI flow of 3 (per visual estimation).
  • No angiographic complications (e.g., distal embolization, side branch closure).
  • No dissections National Heart, Lung, and Blood Institute (NHLBI) grade D-F.
  • No chest pain lasting > 5 minutes.
  • No ST depression or elevation lasting > 5 minutes.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fuwai Yunnan Cardiovascular Hospital

    Kunming

Other trials in China

About this study

Official title: A Prospective, Multi-Center, Single-Blinded, Randomized Trial of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System in Patients With Coronary Artery Disease: IRONMAN-II

A prospective, multi-center, single-blinded, randomized trial to assess the safety and efficacy of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS) in treating patients with coronary artery disease compared to the Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE).

Read the detailed description

IRONMAN-II is a prospective, multi-center, single-blinded, randomized trial to assess the safety and efficacy of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS) in treating patients with coronary artery disease compared to the Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE). A total of 518 subjects with coronary artery lesion(s) are intended to participate in this study. Angiographic follow-up will be required at 2 years, and an OCT subset including 50 subjects will undergo OCT follow-up. Clinical follow-up will be required at postoperative, 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. The primary endpoint is late lumen loss at 2 years.

The primary objective of this trial is to support the China pre-market approval of IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System. IRONMAN-II will evaluate the safety and efficacy of the IBS in treating patients with coronary artery disease. The primary endpoint is late lumen loss at 2 years.

The powered secondary objective is to evaluate long-term vascular function and patency of the IBS treated segments compared to XIENCE treated segments. The powered secondary endpoints include Quantitative Flow Ratio (QFR) and cross-section level mean flow area measured by OCT for OCT subset at 2 years.

Data from the primary endpoint and two powered secondary endpoints will evaluate the non-inferiority of the IBS as compared to XIENCE.

Being tested
Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS), Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System
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 Iron Bioresorbable Coronary Scaffold System (IBS)Device

    Subjects in this arm will be treated with IBS

  • Abbott Vascular XIENCE Everolimus Eluting Coronary Stent SystemDevice

    Subjects in this arm will be treated with XIENCE

Study groups in NCT05206084
Study groupRoleWhat they receive
IBSExperimentalSirolimus-Eluting Iron Bioresorbable Coronary Scaffold System
Receives: Device: Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS)
XIENCEActive comparatorAbbott Vascular XIENCE Everolimus Eluting Coronary Stent System
Receives: Device: Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-segment Late lumen loss (LLL)

    Measured: 2 years

Secondary outcomes (27)

  1. Powered Secondary Endpoint: Quantitative Flow Ratio (QFR)

    Measured: 2 years

  2. Powered Secondary Endpoint: Cross-section level mean flow area measured by OCT

    Only for subjects in OCT subset

    Measured: 2 years

  3. Rate of Device Success

    Device Success is defined as: A visually estimated diameter stenosis of < 30% after implantation of the device and TIMI flow of III.

    Measured: Immediately post-procedure

  4. Rate of Lesion Success

    Lesion Success is defined as: The attainment of visual residual stenosis < 30% and TIMI flow of III after any intervention in target lesion.

    Measured: Immediately post-procedure

  5. Rate of Clinical Success

    Clinical Success is defined as: lesion success, AND there is no major adverse cardiac event in the hospitalization period.

    Measured: ≤ 7 days post the index procedure (In-hospital )

  6. Rate of Device-oriented Composite Endpoint (DoCE)

    Target Lesion Failure (TLF), defined as the composited endpoints of cardiac death/Target Vessel Myocardial Infarction (TV-MI)/Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years

  7. Rate of Patient-oriented Composite Endpoint (PoCE)

    Including all-cause mortality, any myocardial infarction and any revascularization.

    Measured: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years

  8. Rate of Death (Cardiac, Vascular and Non-cardiovascular)

    Measured: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years

  9. Rate of Myocardial infarction (Attributable to target vessel (TV-MI),or Not attributable to target vessel (NTV-MI))

    Measured: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years

  10. Rate of Target Lesion Revascularization (Ischemia driven, or not ischemia driven)

    Measured: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years

  11. Rate of Target Vessel Revascularization (Ischemia driven, or not ischemia driven)

    Measured: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years

  12. Rate of all coronary revascularization

    Measured: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years

  13. Rate of Stent Thrombosis defined by ARC (definite and probable)

    Stent thrombosis is defined by Academic Research Consortium (ARC) criteria as definite, probable, and possible. Stent thrombosis was categorized as acute, Subacute, late, very late.

    Measured: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years

  14. Acute recoil

    Measured: Immediately post-procedure

  15. Minimal lumen diameter (MLD) (In-stent, in-segment, proximal 5mm and distal 5mm MLD)

    Measured: at post-procedure, 2 years

  16. Diameter stenosis (DS %) (In-device, in-segment, proximal 5mm and distal 5mm DS%)

    Measured: at post-procedure, 2 years

  17. Late Lumen Loss (LLL) (In-device, proximal 5mm and distal 5mm LLL)

    Measured: 2 years

  18. Angiographic binary restenosis (ABR) (In-device, in-segment, proximal 5mm and distal 5mm ABR)

    Measured: 2 years

  19. Thickness of neointima (struts level)

    Measured: 2 years

  20. Minimal lumen area

    Measured: 2 years

  21. Percentage of neointima-covered struts

    Measured: 2 years

  22. Late incomplete strut apposition

    Measured: 2 years

  23. Lumen area stenosis %

    Measured: 2 years

  24. Healing score

    Healing score = (presence of intra-scaffold structure * 4) + (presence of both malapposed and uncovered struts * 3) + (presence of uncovered struts alone * 2) + (presence of malapposition alone * 1).

    Measured: 2 years

  25. Stent Absorption (%)

    Measured: 2 years

  26. Late recoil area

    Measured: 2 years

  27. Late recoil proportion

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2022
  2. Study start10 Mar 2022
  3. Primary completion29 Dec 2024
  4. Study completionJan 2028 (estimated)

Resources

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
Participant
Enrolment
518 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05206084
Sponsor's protocol ID
IBS II
Acronym
IRONMAN-II
Status last verified
Dec 2025
First submitted
20 Dec 2021
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Gao R, Song L, Fu G, Guan C, Li Y, Jia S, He Y, Chen J, Qi F, Yu M, Yang B, Zhang Y, Zhang Z, He S, Chen Y, Ma Y, Zhou Y, Wang L, Zhao G, Qian J, Guo N, Sun Z, Huang Y, Li W, Wang Y, Ge J, Han Y, Stone GW; IRONMAN II Investigators. Sirolimus-Eluting Iron Bioresorbable Scaffolds vs Everolimus-Eluting Stents for Percutaneous Coronary Intervention: A Randomized Trial (IRONMAN II). J Am Coll Cardiol. 2026 Apr 28;87(16):2117-2130. doi: 10.1016/j.jacc.2025.12.024. Epub 2026 Feb 11.

    PubMed 41670556

Questions about this trial

What is this clinical trial studying?

A study testing Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS) and Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System in people with Coronary Artery Disease, run by Biotyx Medical (Shenzhen) Co., Ltd. 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 9 inclusion and 45 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: under way, not looking for participants, as of the sponsor's last update on 10 Dec 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 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?

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?

In-segment Late lumen loss (LLL) (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 NCT05206084, 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 10 Dec 2025.

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