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New dissolvable stent could revolutionize heart disease treatment

NCT ID NCT02890160

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a new device called Firesorb, a temporary scaffold that slowly releases medicine to keep heart arteries open and then dissolves over time. Researchers compared it to a standard permanent stent in 430 people with coronary artery disease. The goal was to see if the scaffold works as well or better at maintaining artery openness after one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Firesorb (sirolimus-eluting bioresorbable scaffold)
What this could lead to
If successful, this could offer a safer, temporary scaffold for blocked arteries that dissolves over time, potentially reducing long-term complications.
What could go wrong
This is a mid-stage trial with 430 participants, so results may not apply to everyone. The scaffold might not perform as well as permanent stents, and risks like blood clots or artery re-narrowing remain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

430 people

The number who actually took part.

Started

Aug 2017

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

General Inclusion Criteria: 1. 18-75 years of age, males or non-pregnant females; 2. With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction; 3. Patients with indications for coronary artery bypass graft surgery; 4. To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up. Angiographic Inclusion Criteria: 1. One or two de novo target lesions: 1. If there is one target lesion, a second 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, uncomplicated result prior to randomization of the target lesion. 2. If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria. 3. The definition of epicardial vessels means the LAD, LCX and RCA and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch. 2. Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed % diameter stenosis (DS) of ≥ 50% and \< 100% with a thrombolysis in myocardial infarction (TIMI) flow of ≥1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g. fractional flow reserve, stress test), unstable angina or post-infarct angina. Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.5 mm and ≤4.0 mm. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 25 mm. 3. Each target lesion may be covered with one stent. General Exclusion Criteria: 1. Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal; 2. Implantation of stent in target vessel within 1 year , patients with planned intervention again within six months; 3. Severe congestive heart failure (NYHA III and above) ,or left ventricular ejection fraction \<40% (ultrasound or left ventricular angiography); 4. Preoperative renal function serum creatinine \>2.0mg/DL; receiving hemodialysis; 5. Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy; 6. Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies; 7. The patient's life expectancy is less than 12 months; 8. Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame; 9. Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements; 10. Heart transplantation patients; 11. The unstable arrhythmia, such as high risk ventricular extrasystole and ventricular tachycardia; 12. Cancer need chemotherapy; 13. Immunosuppression and autoimmune diseases, planned or undergoing immunosuppressive therapy; 14. Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc; 15. Within six months for elective surgery requires stopping aspirin, Clopidogrel patients; 16. Blood test prompted platelet counts of less than 100x10E9/L or greater than 700x10E9/L, white blood cells than 3x10E9/L; known or suspected liver disease (such as hepatitis); 17. Peripheral vascular disease, 6F catheter is not available. Angiographic Exclusion Criteria: 1. left main coronary artery disease; 2. severe triple vessel lesion and required revascularization. The following exclusion criteria apply to the target lesion(s) or target vessel(s): 1. Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium). 2. Lesion located within 3 mm of the origin of the Left Anterior Descending Artery (LAD) or left circumflex artery (LCX). 3. Lesion involving a bifurcation with a: 1. side branch ≥ 2.5 mm in diameter, or 2. side branch with diameter stenosis ≥ 50%, or 3. side branch requiring guide wire, or 4. side branch requiring dilatation. 4. Anatomy proximal to or within the lesion that may impair delivery of Firesorb or XIENCE stent: 1. Extreme angulation (≥ 90°) proximal to or within the target lesion. 2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion. 3. Moderate or heavy calcification proximal to or within the target lesion. 5. Lesion or vessel involves a myocardial bridge. 6. Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT. 7. Vessel has been previously treated with a stent at any time prior to the index procedure such that the Firesorb or XIENCE would need to cross the stent to reach the target lesion. 8. Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion. 9. Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes: 1. Residual %DS is a maximum of \< 40% (per visual estimation), ≤ 20% is strongly recommended. 2. TIMI Grade-3 flow (per visual estimation). 3. No angiographic complications (e.g. distal embolization, side branch closure). 4. No dissections National Heart Lung and Blood Institute (NHLBI) grade D-F. 5. No chest pain lasting \> 5 minutes. 6. No ST depression or elevation lasting \> 5 minutes.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Fu Wai Hospital

    Beijing, Beijing Municipality, 100037, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.