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

NCT05209412 | Unknown DMC

• 1 other identifier: CAGE-FREE III
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Coronary fraction flow reserve (FFR) value

  12 months

Secondary Outcomes (1)

• In segment Late lumen loss (LLL)

  12 months

Other Outcomes (6)

• Procedural success rate

  7 days

• Percentage of lesion segments diameter stenosis (DS%)

  12 months

• Binary restenosis (DS% ≥ 50%)

  12 months

Study Arms (2)

Drug-coated balloon

EXPERIMENTAL

Lepu Paclitaxel coated balloon will be used

Device: Lepu Paclitaxel coated balloon; Drug: Aspirin; Drug: Ticagrelor; Drug: Clopidogrel

Drug-eluting stent

ACTIVE COMPARATOR

Resolute Integrity Zotarolimus eluting stents will be used

Device: Resolute Integrity Zotarolimus eluting stents; Drug: Aspirin; Drug: Ticagrelor; Drug: Clopidogrel

Interventions

Lepu Paclitaxel coated balloon DEVICE

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.

Drug-coated balloon

Resolute Integrity Zotarolimus eluting stents DEVICE

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).

Drug-eluting stent

Aspirin DRUG

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

Drug-coated balloon; Drug-eluting stent

Ticagrelor DRUG

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

Drug-coated balloon; Drug-eluting stent

Clopidogrel DRUG

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

Drug-coated balloon; Drug-eluting stent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• y ≤ 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Ling Tao

Xi'an, Shannxi, 710032, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin; Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Ling Tao, M.D, Ph.D

  Xijing Hospital

  STUDY CHAIR

• Chao Gao, M.D, Ph.D

  Xijing Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Cardiology, Director of the department of Cardiology

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 26, 2022
• Study Start: February 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2025
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

CN (1)