De Novo StenosisCAGE-FREEIIINCT05209412

Paclitaxel-Coated Balloon Versus Zotarolimus-Eluting Stent for Treatment of De Novo Coronary Artery Lesions

A study testing Lepu Paclitaxel coated balloon, Resolute Integrity Zotarolimus eluting stents and Aspirin in people with De Novo Stenosis and Coronary Artery Disease, run by Xijing Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: De Novo Stenosis, Coronary Artery Disease, Percutaneous Coronary Intervention
What is being tested?: Lepu Paclitaxel coated balloon, Resolute Integrity Zotarolimus eluting stents and Aspirin
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 370 participants
Where: 1 siteChina
Study dates: 1 Feb 2022to 1 Feb 2025
Phase: Interventional
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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18y ≤ age ≤ 80y;
De-novo coronary artery lesions with an indication for PCI;
Target lesion diameter stenosis ≥ 70% (visual) or ≥ 50% (visual) with evidence of ischemia;
Target lesion reference vessel diameter (2.5mm-4.0 mm), Length of a single target lesion ≤ 35mm; Total treated lesion length ≤ 60 mm;
Vessels treated ≤ 2; only one DCB/DES is allowed for each target vessel;
≤ 2 non-target lesions (non-TL) are allowed, and can not be in the same vessel as the target lesion (randomization should be implemented only after the successful treatment of all non-TL);
Patients who are able to complete the follow-up and compliant to the prescribed medication.

Who cannot join

Myocardial infarction (< 7 days);
Heavy thrombotic burden in target vessel;
eGFR < 30ml/min or hemodialysis patients;
Other cardiovascular and cerebrovascular procedures planned within 12 months after index PCI;
Patients with contraindications to antiplatelet agents and anticoagulants or bleeding tendency, history of active peptic ulcer, and stroke within 6 months;
Life expectancy of less than 1 years;

Show all 18Show fewer

Patient is a woman who is pregnant or nursing;
Known allergic to medications such as Aspirin, Heparin, antiplatelet drugs, paclitaxel, or contrast; patients with systemic lupus erythematosus or other systemic immune diseases;
Chronic total occlusion lesion;
Unprotected left main disease;
Bifurcation lesion requiring 2 stents;
Ostial lesions, distance from left main ≤ 2mm;
Severe calcification or distortion;
Arterial, venous or prosthetic grafts;
In-stent stenosis requiring revascularization (defined as stenosis≥50% by visual or positive functional assessments in any vessel);
Myocardial bridging located at target lesions;
Currently participating in another trial and not yet at its primary endpoint;
Participants deemed unsuitable to be enrolled by investigators for unable to comply with protocol or other reasons.

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 Versus Zotarolimus-Eluting Stent for Treatment of De Novo Coronary Artery Lesions: an Open-label, Multicenter, Randomized, Non-inferiority Trial

Coronary restenosis has been one of the main reasons affecting the prognosis of patients with coronary artery disease (CAD) after percutaneous coronary intervention (PCI). With drug-eluting stents (DES), which elutes an antiproliferative drug to the vessel wall and reduces the restenosis rate; however, the incidence of restenosis is still about 10%. The 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).

DCB angioplasty has the following advantages compared with DES implantation: Firstly, the drug in DCB is uniformly distributed and released; whereas the drug release of DES via stent platform is uneven -85% of the vascular wall is not covered by the stent strut. Secondly, there is no alloy in the vessel after DCB angioplasty, while the coronary stent platform and polymer might cause temporal or persistent inflammatory response leading to intimal hyperplasia. Finally, there is no metal cage restraining vessel motion after DCB, the physiological function of coronary arteries would be maintained.

Studies with the strategy of DCB angioplasty with bailout stenting have demonstrated safety and efficacy for the small-vessel disease. The application of DCB in large vessels with de novo lesions is still to be investigated. The DEBUT study showed that in high bleeding risk patients aimed using only 1-month DAPT, DCB was superior to BMS in terms of MACE [MACE (cardiovascular mortality, nonfatal myocardial infarction or revascularization of ischemia-reperfusion target lesions)] at 9-month follow-up.

However, there is still a lack of evidence comparing the DCB versus DES in large vessels with de novo lesions. The current study aims to investigate if in patients undergoing PCI for de novo stenoses in large vessels, DCB is non-inferior to DES.

Conditions: De Novo Stenosis, Coronary Artery Disease, Percutaneous Coronary Intervention
Being tested: Lepu Paclitaxel coated balloon, Resolute Integrity Zotarolimus eluting stents, Aspirin, Ticagrelor, Clopidogrel
Keywords: Drug-coated balloons, Fractional flow reserve, Percutaneous coronary intervention, De novo lesions, 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.

Lepu Paclitaxel coated balloonDevice
Paclitaxel is the pharmacologically active substance for anti-neointima. The active drug coating is located on the surface of the balloon, which contains 1.5 μg Paclitaxel per 1 mm2.
Resolute Integrity Zotarolimus eluting stentsDevice
The device consists of a balloon-expandable intracoronary drug-eluting stent pre-mounted on the MicroTrac Rapid Exchange stent delivery system. Drug eluting stent is composed of metal stent, primer and drug coating. The Stent is manufactured from a cobalt alloy (MP35N). The strut thickness is 88.9 μm and the length elements is 0.9 mm. The drug coating consists of the zotarolimus and BioLinx polymer (C10/C19/PVP) system. A coating of polymers loaded with zotarolimus in a formulation applied to the entire surface of the stent at a dose of approximately 1.6 µg/mm2 which results in a maximum nominal drug content of 380 µg on the largest stent (4.0 x 38 mm).
AspirinDrug
Aspirin is required for 3 months be a part of the dual antiplatelet therapy (DAPT) after PCI.
TicagrelorDrug
Ticagrelor is required for 12 months to be a part of the dual antiplatelet therapy (DAPT) after PCI.
ClopidogrelDrug
Clopidogrel is required for 12 months to be a part of the dual antiplatelet therapy (DAPT) after PCI when Ticagrelor is unfeasible or contradicted.

Study groups in NCT05209412
Study group	Role	What they receive
Drug-coated balloon	Experimental	Lepu Paclitaxel coated balloon will be used Receives: Device: Lepu Paclitaxel coated balloon; Drug: Aspirin; Drug: Ticagrelor; Drug: Clopidogrel
Drug-eluting stent	Active comparator	Resolute Integrity Zotarolimus eluting stents will be used Receives: Device: Resolute Integrity Zotarolimus eluting stents; Drug: Aspirin; Drug: Ticagrelor; Drug: Clopidogrel

What is being measured

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

Coronary fraction flow reserve (FFR) value
Measured: 12 months

Secondary outcomes (1)

In segment Late lumen loss (LLL)
Key Secondary Outcome
Measured: 12 months

Timeline

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

1 Feb 20221 Feb 2025

First posted26 Jan 2022
Study start1 Feb 2022
Primary completion1 Feb 2024 (estimated)
Study completion1 Feb 2025 (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: None (open label)
Enrolment: 370 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05209412
Sponsor's protocol ID: CAGE-FREE III
Acronym: CAGE-FREEIII
Status last verified: Jan 2024
First submitted: 12 Jan 2022
Last updated: 24 Jan 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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
Not yet recruitingObservational study
The PICCOLETO XIII REVEAL-DCB Cohort A Study
Coronary Artery Disease, Coronary Stenosis
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

All De Novo Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Paclitaxel-Coated Balloon Versus Zotarolimus-Eluting Stent for Treatment of De Novo Coronary Artery Lesions: an Open-label, Multicenter, Randomized, Non-inferiority Trial
ClinicalTrials.gov ID: NCT05209412
Acronym / sponsor ID: CAGE-FREEIII / CAGE-FREE III
Conditions: De Novo Stenosis, Coronary Artery Disease, Percutaneous Coronary Intervention
Keywords: Drug-coated balloons, Fractional flow reserve, Percutaneous coronary intervention, De novo lesions, Drug-eluting stent
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 370 participants (actual)
Lead sponsor: Xijing HospitalUniversity, hospital or other
Study start: 1 Feb 2022 (actual)
Primary completion: 1 Feb 2024 (estimated)
Study completion: 1 Feb 2025 (estimated)
First posted: 26 Jan 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Drug-coated balloon	Experimental	Device: Lepu Paclitaxel coated balloon, Drug: Aspirin, Drug: Ticagrelor, Drug: ClopidogrelLepu Paclitaxel coated balloon will be used
Drug-eluting stent	Active comparator	Device: Resolute Integrity Zotarolimus eluting stents, Drug: Aspirin, Drug: Ticagrelor, Drug: ClopidogrelResolute Integrity Zotarolimus eluting stents will be used

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

18y ≤ age ≤ 80y;
De-novo coronary artery lesions with an indication for PCI;
Target lesion diameter stenosis ≥ 70% (visual) or ≥ 50% (visual) with evidence of ischemia;
Target lesion reference vessel diameter (2.5mm-4.0 mm), Length of a single target lesion ≤ 35mm; Total treated lesion length ≤ 60 mm;
Vessels treated ≤ 2; only one DCB/DES is allowed for each target vessel;

Key exclusion criteria (18 listed)

Myocardial infarction (< 7 days);
Heavy thrombotic burden in target vessel;
eGFR < 30ml/min or hemodialysis patients;
Other cardiovascular and cerebrovascular procedures planned within 12 months after index PCI;
Patients with contraindications to antiplatelet agents and anticoagulants or bleeding tendency, history of active peptic ulcer, and stroke within 6 months;

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
Lepu Paclitaxel coated balloonPaclitaxel is the pharmacologically active substance for anti-neointima. The active drug coating is located on the surface of the balloon, which contains 1.5 μg Paclitaxel per 1 mm2.	Device	Drug-coated balloon
Resolute Integrity Zotarolimus eluting stentsThe device consists of a balloon-expandable intracoronary drug-eluting stent pre-mounted on the MicroTrac Rapid Exchange stent delivery system. Drug eluting stent is composed of metal stent, primer and drug coating. The Stent is manufactured from a cobalt alloy (MP35N). The strut thickness is 88.9 μm and the length elements is 0.9 mm. The drug coating consists of the zotarolimus and BioLinx polymer (C10/C19/PVP) system. A coating of polymers loaded with zotarolimus in a formulation applied to the entire surface of the stent at a dose of approximately 1.6 µg/mm2 which results in a maximum nominal drug content of 380 µg on the largest stent (4.0 x 38 mm).	Device	Drug-eluting stent
AspirinAspirin is required for 3 months be a part of the dual antiplatelet therapy (DAPT) after PCI.	Drug	Drug-coated balloon, Drug-eluting stent
TicagrelorTicagrelor is required for 12 months to be a part of the dual antiplatelet therapy (DAPT) after PCI.	Drug	Drug-coated balloon, Drug-eluting stent
ClopidogrelClopidogrel is required for 12 months to be a part of the dual antiplatelet therapy (DAPT) after PCI when Ticagrelor is unfeasible or contradicted.	Drug	Drug-coated balloon, Drug-eluting stent

Primary outcome

Coronary fraction flow reserve (FFR) value
Time frame: 12 months

1 secondary outcome

In segment Late lumen loss (LLL)
Time frame: 12 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.

Related trials for De Novo Stenosis

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
Not yet recruitingObservational study
The PICCOLETO XIII REVEAL-DCB Cohort A Study
Coronary Artery Disease, Coronary Stenosis
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

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

Chao Gao, M.D, Ph.D study chair

Xijing Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 18 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 24 Jan 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?

Results are not available in the source record.

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?

Coronary fraction flow reserve (FFR) value (time frame: 12 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 NCT05209412.

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 24 Jan 2024.