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Paclitaxel-Coated Balloon Versus Zotarolimus-Eluting Stent for Treatment of De Novo Coronary Artery Lesions (CAGE-FREE III)

Primary Purpose

De Novo Stenosis, Coronary Artery Disease, Percutaneous Coronary Intervention

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Lepu Paclitaxel coated balloon

Resolute Integrity Zotarolimus eluting stents

Aspirin

Ticagrelor

Clopidogrel

About this trial

This is an interventional treatment trial for De Novo Stenosis focused on measuring Drug-coated balloons, Fractional flow reserve, Percutaneous coronary intervention, De novo lesions, Drug-eluting stent

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18y ≤ age ≤ 80y;
De-novo coronary artery lesions with 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.

Exclusion Criteria:

Myocardial infarction (< 7 days);
Heavy thrombotic burden in target vessel;
eGFR < 30ml/min or hemodialysis patients;
Other cardiovascular and cerebrovascular percedures 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;
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 unsutable to be enrolled by investigators for unable to comply to protocol or other reasons.

Sites / Locations

Ling TaoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug-coated balloon

Drug-eluting stent

Arm Description

Lepu Paclitaxel coated balloon will be used

Resolute Integrity Zotarolimus eluting stents will be used

Outcomes

Primary Outcome Measures

Coronary fraction flow reserve (FFR) value

Secondary Outcome Measures

In segment Late lumen loss (LLL)

Key Secondary Outcome

Full Information

NCT ID

NCT05209412

First Posted

January 12, 2022

Last Updated

July 20, 2022

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05209412

Brief Title

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

Acronym

CAGE-FREE III

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2022 (Actual)

Primary Completion Date

February 1, 2024 (Anticipated)

Study Completion Date

February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

370 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Drug-coated balloon

Arm Type

Experimental

Arm Description

Lepu Paclitaxel coated balloon will be used

Arm Title

Drug-eluting stent

Arm Type

Active Comparator

Arm Description

Resolute Integrity Zotarolimus eluting stents will be used

Intervention Type

Device

Intervention Name(s)

Lepu Paclitaxel coated balloon

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Resolute Integrity Zotarolimus eluting stents

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Aspirin

Intervention Description

Aspirin is required for 3 months be a part of the dual antiplatelet therapy (DAPT) after PCI.

Intervention Type

Drug

Intervention Name(s)

Ticagrelor

Intervention Description

Ticagrelor is required for 12 months to be a part of the dual antiplatelet therapy (DAPT) after PCI.

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Intervention Description

Clopidogrel is required for 12 months to be a part of the dual antiplatelet therapy (DAPT) after PCI when Ticagrelor is unfeasible or contradicted.

Primary Outcome Measure Information:

Title

Coronary fraction flow reserve (FFR) value

Time Frame

12 months

Secondary Outcome Measure Information:

Title

In segment Late lumen loss (LLL)

Description

Key Secondary Outcome

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Procedural success rate

Description

Procedural success rate included device success, lesion success and procedural success

Time Frame

7 days

Title

Percentage of lesion segments diameter stenosis (DS%)

Time Frame

12 months

Title

Binary restenosis (DS% ≥ 50%)

Time Frame

12 months

Title

Target lesion failure (TLF)

Description

Target lesion failure (TLF), defined as cardiac death, target vessel myocardial infarction (TV-MI) and clinically indicated-target lesion revascularization (CI-TLR)

Time Frame

1, 6, 12 months

Title

Patient-oriented composite endpoint (PoCE)

Description

Patient-oriented composite endpoint (PoCE) defined as all-cause death, any stroke, any MI, and any clinically and indicated revascularisation)

Time Frame

1, 6, 12 months

Title

Definite/Probable Stent thrombosis rates

Description

Stent thrombosis included acute, subacute, late and very late thrombosis

Time Frame

1, 6, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18y ≤ age ≤ 80y; De-novo coronary artery lesions with 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. Exclusion Criteria: Myocardial infarction (< 7 days); Heavy thrombotic burden in target vessel; eGFR < 30ml/min or hemodialysis patients; Other cardiovascular and cerebrovascular percedures 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; 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 unsutable to be enrolled by investigators for unable to comply to protocol or other reasons.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chao Gao, M.D, Ph.D

Phone

+86-18629551066

woshigaochao@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ling Tao, M.D, Ph.D

Organizational Affiliation

Xijing Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Chao Gao, M.D, Ph.D

Organizational Affiliation

Xijing Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Ling Tao

City

Xi'an

State/Province

Shannxi

ZIP/Postal Code

710032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chao Gao

woshigaochao@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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