De Novo StenosisNCT04561739

Paclitaxel-coated Balloon for Treatment of De-novo Non-complex Coronary Artery Lesions

A study testing Paclitaxel coated balloon and Sirolimus eluting stents in people with De Novo Stenosis and Coronary Artery Disease, run by Xijing Hospital 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

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: De Novo Stenosis, Coronary Artery Disease
What is being tested?: Paclitaxel coated balloon and Sirolimus eluting stents
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,272 participants
Where: 1 siteChina
Study dates: 1 Feb 2021to 5 May 2027
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with an indication for PCI due to acute or chronic coronary syndrome
Patients with de-novo, non-complex lesion* and underwent successful pre-dilation**
Patients who are able to complete the follow-up and compliant to the prescribed medication
Non-complex PCI is defined as
1. Vessels treated<3; stents implanted<3; lesions treated<3 or Total stent length<60 mm 2. Bifurcation does not require 2 stents 3. Non left main lesion 4. Non venous or arterial graft lesion 5. Non chronic total occlusion lesion 6. Do not require the use of atherectomy device
Successful pre-dilation is defined as fulfilling all the following criteria

Show all 10Show fewer

Thrombolysis In Myocardial Infarction [TIMI] flow =3
Without dissections type D, E, and F
Residual stenoses <30% after balloon pre-dilation (visual).
Without serious complication requiring the termination of PCI

Who cannot join

Under the age of 18
Unable to give informed consent
The patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
Known contraindication to medications such as Heparin, antiplatelet drugs, or contrast.
Currently participating in another trial and not yet at its primary endpoint
The concurrent medical condition with a life expectancy of less than 2 years

Show all 11Show fewer

Previous intracranial hemorrhage
In-stent stenosis requiring revascularization (defined as stenosis≥50% by visual or positive functional assessments in any vessel)
Atrial fibrillation
Prior CABG
Cardiogenic shock

Trial locations and contacts

1 site in 1 country.

China1 site

Ling Tao
Xi'an, Shannxi, 710032

Other trials in China

About this study

Official title: Paclitaxel-coated Balloon for the Treatment of De-novo Non-complex Coronary Artery Lesions: an Open-label, Multicentre, Randomised, Non-inferiority Trial

The introduction of Bare-metal stents (BMS) since 1986 has alleviated the limitations of plain old balloon angioplasty (POBA) related elastic recoil and flow-limiting dissections. Later on, higher restenosis rates due to exaggerated neointimal growth in BMS has led to the development of drug-eluting stents (DES), which elutes an antiproliferative drug to the vessel wall and reduce the restenosis rate. However, late stent thrombosis and restenosis, with a hazard of nearly 2% per year after implantation, remained a concern and motivated the development of drug-coated balloons (DCB).

The advantages of DCB are that leaving no metal in the blood vessel and respect the vessel anatomy.

Recently, studies with the strategy of DCB angioplasty with bailout stenting have demonstrated safety and efficacy for the small-vessel disease. In the BASKET-SMALL 2 trial, which compared SeQuent Please DCB with EES or Taxus DES in the vessels that have reference diameter<3mm, showed that at 12-month follow-up, DCB was non-inferior to DES (MACE [cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation] rates: 8% vs. 9%).

Although some small-scale RCT using surrogate endpoints have reported that no significant difference in MLD or late lumen loss between the two groups in large vessels, up to now, there is no large-scale RCT comparing the clinical outcomes of DCB versus DES in large vessels with de novo lesions.

Therefore, the investigators hypothesized that in patients undergoing non-complex percutaneous coronary intervention (PCI) for de-novo stenoses, drug-coated balloon (DCB) is non-inferior to drug-eluting stents (DES).

Conditions: De Novo Stenosis, Coronary Artery Disease
Being tested: Paclitaxel coated balloon, Sirolimus eluting stents
Keywords: drug-coated balloons, percutaneous coronary intervention, de novo stenosis, drug-eluting stent
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.

Paclitaxel coated balloonDevice
The Paclitaxel coated balloon is a paclitaxel-eluting rapid exchange balloon catheter for PTCA. Paclitaxel is the pharmacologically active substance for anti-neointima, whereas iopromide, a well-tolerated nonionic x-ray contrast agent, acts as a release-supporting additive.
The active drug coating is located on the surface of the balloon, which contains 3 μg Paclitaxel per 1 mm2. The spray coating of the mixture of paclitaxel and iopromide of the Swide is via ultrasound, with the crystal size<2um.
Sirolimus eluting stentsDevice
The device has a backbone of L605 cobalt chromium. The stent has a open cell, in-phase, peak-to-valley design. The strut thickness is 86 μm and has a stent profile less than 1.12mm. The polymer coating of the stent is a styrene-butadiene block copolymer. The antiproliferative drug concentration is at 9 ug/mm, which 80% of the drug is released by 30 days.

Study groups in NCT04561739
Study group	Role	What they receive
Drug-coated balloon	Experimental	Not described Receives: Device: Paclitaxel coated balloon
Drug-eluting stent	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.

Device-oriented Composite Endpoint (DoCE)
DoCE is a composite clinical endpoint of Cardiac cause death, Target vessel myocardial infarction (TV-MI), and Clinically and physiologically indicated target lesion revascularization (CI-TLR).
Measured: 24 months

Secondary outcomes (19)

Device-oriented Composite Endpoint (DoCE)
Rates of the DoCE beside the time point of primary endpoint
Measured: 1, 12, 36, and 60 months
Cardiac cause death
Rates of individual components of the DoCE
Measured: 1, 12, 24, 36, and 60 months
Target vessel myocardial infarction (TV-MI)
Rates of individual components of the DoCE
Measured: 1, 12, 24, 36, and 60 months
Clinically and physiologically indicated target lesion revascularization (CI-TLR)
Rates of individual components of the DoCE
Measured: 1, 12, 24, 36, and 60 months
Patient-oriented composite endpoint (PoCE)
Patient-oriented composite endpoint (PoCE) defined as all-cause death, any stroke, any MI, and any clinically and indicated revascularisation)
Measured: 1, 12, 24, 36, and 60 months
All-cause death
individual components of PoCE
Measured: 1, 12, 24, 36, and 60 months
Any MI
individual components of PoCE
Measured: 1, 12, 24, 36, and 60 months
Any stroke
individual components of PoCE
Measured: 1, 12, 24, 36, and 60 months
Any revascularisation
individual components of PoCE
Measured: 1, 12, 24, 36, and 60 months
Any clinically and physiologically indicated revascularisation
Measured: 1, 12, 24, 36, and 60 months
Target vessel failure (TVF)
Target vessel failure, defined as cardiovascular death, TV MI and clinically-indicated target vessel revascularisation
Measured: 1, 12, 24, 36, and 60 months
Clinical and physiologically indicated target vessel revascularization
Measured: 1, 12, 24, 36, and 60 months
Net adverse clinical events (NACE)
Net adverse clinical events (NACE), define as POCE or BARC type 3 or 5 bleeding events
Measured: 1, 12, 24, 36, and 60 months
BARC type 3 or 5 bleeding events
Measured: 1, 12, 24, 36, and 60 months
BARC defined type 2, 3 or 5 bleeding events
Measured: 1, 12, 24, 36, and 60 months
Definite/Probable Stent thrombosis rates
According to ARC-II classification
Measured: 1, 12, 24, 36, and 60 months
Device success
Device success is defined by the following: DCB: 1.Successful delivery within 120 seconds (DCB in vessel) of the DCB device at the intended target lesion; 2.DCB is successfully dilated for at least 30 seconds and the device system is successfully withdrawn; 3.After DCB dilation, the target vessel has no flow limiting dissection (type D, E and F); and the final in-lesion residual stenosis is less than 30% by core laboratory QCA (preferred methodology) or visual assessment; 4.No bailout procedure by stent; DES: 1.1. Successful delivery, balloon expansion, and deployment of the first assigned device, at the intended target lesion; 2.Successful withdrawal of the device delivery system; 3. 3. Attainment of a final in-stent residual stenosis of <20% by core laboratory QCA (preferred methodology) or visual assessment;
Measured: 0 day (during index PCI)
Procedure success during PCI
Device success + without the occurrence of DoCE + no stent thrombosis at discharge during the index procedure hospital stay (maximum of 7 days).
Measured: 7 days
Clinically relevant ischemic or bleeding events
Time from randomization to the occurrence of first any ischemic or bleeding endpoints, including all-cause death, any stroke, MI, BARC-defined type 3 bleeding, any revascularization and BARC-defined type 2 bleeding events
Measured: 1, 12, 24, 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.

1 Feb 20215 May 2027

First posted24 Sep 2020
Study start1 Feb 2021
Primary completion5 May 2024 (estimated)
Study completion5 May 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
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: 2,272 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04561739
Sponsor's protocol ID: CAGE-FREE 1
Status last verified: Mar 2024
First submitted: 3 Sep 2020
Last updated: 29 Mar 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Song B, Sun D, Wang Q, Jiang H, Yin Z, Wen S, Jin Y, Chen H, Yuan M, Zhong L, Hu S, Lian Z, Zeng H, Pan H, Qin X, Xia Y, Mou F, Yang W, Yan W, Zhang F, Garg S, Onuma Y, Wang D, Serruys PW, Gao C, Tao L. Effect of Left Ventricular Ejection Fraction on Outcomes With Drug-coated Balloons vs Drug-Eluting Stents for De Novo Coronary Artery Disease. Can J Cardiol. 2026 May 25:S0828-282X(26)00507-6. doi: 10.1016/j.cjca.2026.05.011. Online ahead of print.
PubMed 42190985
Zhu B, Li F, Liu J, Ma L, Yang F, Ji Z, Wang H, Wu Y, Fang Z, Zhou J, Gao H, Hu T, Sun D, Wang Q, Jiang H, Fu G, Zhang R, He X, Xu X, Jiang Z, Xia J, Wang D, Capodanno D, Onuma Y, Serruys PW, Garg S, Tao L, Gao C; REC-CAGEFREE I Investigators. Drug-Coated Balloon Angioplasty vs Drug-Eluting Stents in Noncomplex Coronary Bifurcation Lesions: The REC-CAGEFREE I Trial. JACC Cardiovasc Interv. 2026 Apr 27;19(8):943-957. doi: 10.1016/j.jcin.2026.02.009. Epub 2026 Mar 26.
PubMed 41885677
Wang P, Zhou J, Gao H, Hu T, Sun D, Wang Q, Jiang H, Yin Z, Wen S, Jin Y, Chen H, Yuan M, Zhong L, Hu S, Lian Z, Jiang Z, Xia J, Liu J, Fu G, He X, Zhu B, Garg S, Onuma Y, Wang D, Serruys PW, Gao C, Tao L. Impact of sex on outcomes in patients treated with drug-coated balloons versus drug-eluting stents for de novo coronary artery lesions: Insights from the REC-CAGEFREE I trial. BMC Med. 2026 Jan 22;24(1):102. doi: 10.1186/s12916-026-04649-7.
PubMed 41572254
Bai X, Gao H, Lv Y, Sun D, Wang Q, Yin Z, Wen S, Jin Y, Chen H, Yuan M, Zhong L, Hu S, Lian Z, Zeng H, Pan H, Liu J, Fu G, Zhang R, He X, Capodanno D, Garg S, Onuma Y, Wang D, Serruys PW, Gao C, Tao L. Impact of Chronic Kidney Disease on Outcomes With Drug-Coated Balloons Versus Drug-Eluting Stents: Insights From the REC-CAGEFREE I Trial. Catheter Cardiovasc Interv. 2026 Jan;107(1):304-314. doi: 10.1002/ccd.70348. Epub 2025 Nov 20.
PubMed 41264778
Tao L, He X, Shen G, Wu M, He Y, Ma L, Yang F, Ji Z, Wang H, Wu Y, Fang Z, Jiang H, Wen S, Jin Y, Chen H, Zhong L, Hu S, Liu Y, Li F, Zhou J, Ouyang F, Zhang Z, Zhu B, Zhang R, Fu G, Liu J, Jiang Z, Wang D, Capodanno D, Garg S, Onuma Y, Serruys PW, Gao C; REC-CAGEFREE I Investigators. Drug-Coated Balloon Angioplasty vs Up-Front Stenting for De Novo CAD: 3-Year Follow-Up of REC-CAGEFREE I Trial. J Am Coll Cardiol. 2026 Jan 27;87(3):312-329. doi: 10.1016/j.jacc.2025.10.027. Epub 2025 Oct 27.
PubMed 41194754
Gao C, He X, Ouyang F, Zhang Z, Shen G, Wu M, Yang P, Ma L, Yang F, Ji Z, Wang H, Wu Y, Fang Z, Jiang H, Wen S, Liu Y, Li F, Zhou J, Zhu B, Liu Y, Zhang R, Zhang T, Wang P, Liu J, Jiang Z, Xia J, van Geuns RJ, Capodanno D, Garg S, Onuma Y, Wang D, Serruys PW, Tao L; REC-CAGEFREE I Investigators. Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial. Lancet. 2024 Sep 14;404(10457):1040-1050. doi: 10.1016/S0140-6736(24)01594-0. Epub 2024 Sep 2.
PubMed 39236727
Gao C, He X, Liu Y, Liu J, Jiang Z, Zhu B, Qin X, Xia Y, Zhang T, Wang P, Zhang R, Onuma Y, Xia J, Wang D, Serruys P, Tao L. Drug-coated balloon angioplasty with provisional stenting versus primary stenting for the treatment of de novo coronary artery lesions: REC-CAGEFREE I trial rationale and design. BMC Cardiovasc Disord. 2024 Jun 24;24(1):319. doi: 10.1186/s12872-024-03974-0.
PubMed 38914951

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
Coronary Artery Disease, De Novo Stenosis Lesion
Active, not recruiting
STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) Trial
Drug-coated Balloon, Drug-eluting Stent
Recruiting
First-in-Human Study Using the SiroMax™ Sirolimus-Coated Balloon Catheter as a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to Treat Subjects Who Have Coronary Artery Disease (CAD) Involving In-Stent Restenosis (ISR) or an Unstented Lesion in a Small Coronary Vessel (DNSV).
Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Active, not recruiting
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
Coronary Artery Disease, Myocardial Ischemia
Recruiting
Bioresorbable Sirolimus-eluting scaﬀold in de Novo Coronary Artery Lesions
De Novo Stenosis, Coronary Artery Disease

All De Novo Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Paclitaxel-coated Balloon for the Treatment of De-novo Non-complex Coronary Artery Lesions: an Open-label, Multicentre, Randomised, Non-inferiority Trial
ClinicalTrials.gov ID: NCT04561739
Acronym / sponsor ID: CAGE-FREE 1
Conditions: De Novo Stenosis, Coronary Artery Disease
Keywords: drug-coated balloons, percutaneous coronary intervention, de novo stenosis, drug-eluting stent
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 2,272 participants (actual)
Lead sponsor: Xijing HospitalUniversity, hospital or other
Study start: 1 Feb 2021 (actual)
Primary completion: 5 May 2024 (estimated)
Study completion: 5 May 2027 (estimated)
First posted: 24 Sep 2020 (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 advantages of DCB are that leaving no metal in the blood vessel and respect the vessel anatomy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Drug-coated balloon	Experimental	Device: Paclitaxel coated balloon
Drug-eluting stent	Active comparator	Device: Sirolimus eluting stents

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Patients with an indication for PCI due to acute or chronic coronary syndrome
Patients with de-novo, non-complex lesion* and underwent successful pre-dilation**
Patients who are able to complete the follow-up and compliant to the prescribed medication
1. Vessels treated<3; stents implanted<3; lesions treated<3 or Total stent length<60 mm 2. Bifurcation does not require 2 stents 3. Non left main lesion 4. Non venous or arterial graft lesion 5. Non chronic total occlusion lesion 6. Do not require the use of atherectomy device
Successful pre-dilation is defined as fulfilling all the following criteria

Key exclusion criteria (11 listed)

Under the age of 18
Unable to give informed consent
The patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
Known contraindication to medications such as Heparin, antiplatelet drugs, or contrast.
Currently participating in another trial and not yet at its primary endpoint

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
Paclitaxel coated balloonThe Paclitaxel coated balloon is a paclitaxel-eluting rapid exchange balloon catheter for PTCA. Paclitaxel is the pharmacologically active substance for anti-neointima, whereas iopromide, a well-tolerated nonionic x-ray contrast agent, acts as a release-supporting additive. The active drug coating is located on the surface of the balloon, which contains 3 μg Paclitaxel per 1 mm2. The spray coating of the mixture of paclitaxel and iopromide of the Swide is via ultrasound, with the crystal size<2um.	Device	Drug-coated balloon
Sirolimus eluting stentsThe device has a backbone of L605 cobalt chromium. The stent has a open cell, in-phase, peak-to-valley design. The strut thickness is 86 μm and has a stent profile less than 1.12mm. The polymer coating of the stent is a styrene-butadiene block copolymer. The antiproliferative drug concentration is at 9 ug/mm, which 80% of the drug is released by 30 days.	Device	Drug-eluting stent

Primary outcome

Device-oriented Composite Endpoint (DoCE)
Time frame: 24 months
DoCE is a composite clinical endpoint of Cardiac cause death, Target vessel myocardial infarction (TV-MI), and Clinically and physiologically indicated target lesion revascularization (CI-TLR).

19 secondary outcomes

Device-oriented Composite Endpoint (DoCE)
Time frame: 1, 12, 36, and 60 months
Cardiac cause death
Time frame: 1, 12, 24, 36, and 60 months
Target vessel myocardial infarction (TV-MI)
Time frame: 1, 12, 24, 36, and 60 months
Clinically and physiologically indicated target lesion revascularization (CI-TLR)
Time frame: 1, 12, 24, 36, and 60 months
Patient-oriented composite endpoint (PoCE)
Time frame: 1, 12, 24, 36, and 60 months
All-cause death
Time frame: 1, 12, 24, 36, and 60 months
Any MI
Time frame: 1, 12, 24, 36, and 60 months
Any stroke
Time frame: 1, 12, 24, 36, and 60 months
Any revascularisation
Time frame: 1, 12, 24, 36, and 60 months
Any clinically and physiologically indicated revascularisation
Time frame: 1, 12, 24, 36, and 60 months
Target vessel failure (TVF)
Time frame: 1, 12, 24, 36, and 60 months
Clinical and physiologically indicated target vessel revascularization
Time frame: 1, 12, 24, 36, and 60 months
Net adverse clinical events (NACE)
Time frame: 1, 12, 24, 36, and 60 months
BARC type 3 or 5 bleeding events
Time frame: 1, 12, 24, 36, and 60 months
BARC defined type 2, 3 or 5 bleeding events
Time frame: 1, 12, 24, 36, and 60 months
Definite/Probable Stent thrombosis rates
Time frame: 1, 12, 24, 36, and 60 months
Device success
Time frame: 0 day (during index PCI)
Procedure success during PCI
Time frame: 7 days
Clinically relevant ischemic or bleeding events
Time frame: 1, 12, 24, 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 29 Mar 2024.
Derived from this study: PubMed 42190985Song B, Sun D, Wang Q, Jiang H, Yin Z, Wen S, Jin Y, Chen H, Yuan M, Zhong L, Hu S, Lian Z, Zeng H, Pan H, Qin X, Xia Y, Mou F, Yang W, Yan W, Zhang F, Garg S, Onuma Y, Wang D, Serruys PW, Gao C, Tao L. Effect of Left Ventricular Ejection Fraction on Outcomes With Drug-coated Balloons vs Drug-Eluting Stents for De Novo Coronary Artery Disease. Can J Cardiol. 2026 May 25:S0828-282X(26)00507-6. doi: 10.1016/j.cjca.2026.05.011. Online ahead of print.
Derived from this study: PubMed 41885677Zhu B, Li F, Liu J, Ma L, Yang F, Ji Z, Wang H, Wu Y, Fang Z, Zhou J, Gao H, Hu T, Sun D, Wang Q, Jiang H, Fu G, Zhang R, He X, Xu X, Jiang Z, Xia J, Wang D, Capodanno D, Onuma Y, Serruys PW, Garg S, Tao L, Gao C; REC-CAGEFREE I Investigators. Drug-Coated Balloon Angioplasty vs Drug-Eluting Stents in Noncomplex Coronary Bifurcation Lesions: The REC-CAGEFREE I Trial. JACC Cardiovasc Interv. 2026 Apr 27;19(8):943-957. doi: 10.1016/j.jcin.2026.02.009. Epub 2026 Mar 26.
Derived from this study: PubMed 41572254Wang P, Zhou J, Gao H, Hu T, Sun D, Wang Q, Jiang H, Yin Z, Wen S, Jin Y, Chen H, Yuan M, Zhong L, Hu S, Lian Z, Jiang Z, Xia J, Liu J, Fu G, He X, Zhu B, Garg S, Onuma Y, Wang D, Serruys PW, Gao C, Tao L. Impact of sex on outcomes in patients treated with drug-coated balloons versus drug-eluting stents for de novo coronary artery lesions: Insights from the REC-CAGEFREE I trial. BMC Med. 2026 Jan 22;24(1):102. doi: 10.1186/s12916-026-04649-7.
Derived from this study: PubMed 41264778Bai X, Gao H, Lv Y, Sun D, Wang Q, Yin Z, Wen S, Jin Y, Chen H, Yuan M, Zhong L, Hu S, Lian Z, Zeng H, Pan H, Liu J, Fu G, Zhang R, He X, Capodanno D, Garg S, Onuma Y, Wang D, Serruys PW, Gao C, Tao L. Impact of Chronic Kidney Disease on Outcomes With Drug-Coated Balloons Versus Drug-Eluting Stents: Insights From the REC-CAGEFREE I Trial. Catheter Cardiovasc Interv. 2026 Jan;107(1):304-314. doi: 10.1002/ccd.70348. Epub 2025 Nov 20.
Derived from this study: PubMed 41194754Tao L, He X, Shen G, Wu M, He Y, Ma L, Yang F, Ji Z, Wang H, Wu Y, Fang Z, Jiang H, Wen S, Jin Y, Chen H, Zhong L, Hu S, Liu Y, Li F, Zhou J, Ouyang F, Zhang Z, Zhu B, Zhang R, Fu G, Liu J, Jiang Z, Wang D, Capodanno D, Garg S, Onuma Y, Serruys PW, Gao C; REC-CAGEFREE I Investigators. Drug-Coated Balloon Angioplasty vs Up-Front Stenting for De Novo CAD: 3-Year Follow-Up of REC-CAGEFREE I Trial. J Am Coll Cardiol. 2026 Jan 27;87(3):312-329. doi: 10.1016/j.jacc.2025.10.027. Epub 2025 Oct 27.
Derived from this study: PubMed 39236727Gao C, He X, Ouyang F, Zhang Z, Shen G, Wu M, Yang P, Ma L, Yang F, Ji Z, Wang H, Wu Y, Fang Z, Jiang H, Wen S, Liu Y, Li F, Zhou J, Zhu B, Liu Y, Zhang R, Zhang T, Wang P, Liu J, Jiang Z, Xia J, van Geuns RJ, Capodanno D, Garg S, Onuma Y, Wang D, Serruys PW, Tao L; REC-CAGEFREE I Investigators. Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial. Lancet. 2024 Sep 14;404(10457):1040-1050. doi: 10.1016/S0140-6736(24)01594-0. Epub 2024 Sep 2.
Derived from this study: PubMed 38914951Gao C, He X, Liu Y, Liu J, Jiang Z, Zhu B, Qin X, Xia Y, Zhang T, Wang P, Zhang R, Onuma Y, Xia J, Wang D, Serruys P, Tao L. Drug-coated balloon angioplasty with provisional stenting versus primary stenting for the treatment of de novo coronary artery lesions: REC-CAGEFREE I trial rationale and design. BMC Cardiovasc Disord. 2024 Jun 24;24(1):319. doi: 10.1186/s12872-024-03974-0.
Individual participant dataSharing planned: No

Related trials for De Novo Stenosis

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ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
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STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) Trial
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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.

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 Paclitaxel coated balloon 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 10 inclusion and 11 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 29 Mar 2024. 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?

Device-oriented Composite Endpoint (DoCE) (time frame: 24 months). 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 NCT04561739, which also lists 7 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 29 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.