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

Not Applicable

Active, not recruiting

• Conditions: Coronary Artery Disease; De Novo Stenosis
• Interventions: Device: Paclitaxel coated balloon; Device: Sirolimus eluting stents

• Registration Number: NCT04561739
• Lead Sponsor: Xijing Hospital

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-19
• Study First Posted: 2020-09-24
• Study Start: 2021-02-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-29
• Primary Completion: 2024-05-05
• Study Completion: 2027-05-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2272

Inclusion Criteria

1. Patients with an indication for PCI due to acute or chronic coronary syndrome

2. Patients with de-novo, non-complex lesion* and underwent successful pre-dilation**

3. Patients who are able to complete the follow-up and compliant to the prescribed medication

   • Non-complex PCI is defined as

4. 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

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

Exclusion Criteria

1. Under the age of 18
2. Unable to give informed consent
3. 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)
4. Known contraindication to medications such as Heparin, antiplatelet drugs, or contrast.
5. Currently participating in another trial and not yet at its primary endpoint
6. The concurrent medical condition with a life expectancy of less than 2 years
7. Previous intracranial hemorrhage
8. In-stent stenosis requiring revascularization (defined as stenosis≥50% by visual or positive functional assessments in any vessel)
9. Atrial fibrillation
10. Prior CABG
11. Cardiogenic shock

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug-coated balloon	Paclitaxel coated balloon	-
Drug-eluting stent	Sirolimus eluting stents	-

Primary Outcome Measures

Name	Time	Method
Device-oriented Composite Endpoint (DoCE)	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).

Secondary Outcome Measures

Name	Time	Method
Any MI	1, 12, 24, 36, and 60 months	individual components of PoCE
Device-oriented Composite Endpoint (DoCE)	1, 12, 36, and 60 months	Rates of the DoCE beside the time point of primary endpoint
Cardiac cause death	1, 12, 24, 36, and 60 months	Rates of individual components of the DoCE
Clinically and physiologically indicated target lesion revascularization (CI-TLR)	1, 12, 24, 36, and 60 months	Rates of individual components of the DoCE
Any revascularisation	1, 12, 24, 36, and 60 months	individual components of PoCE
Clinical and physiologically indicated target vessel revascularization	1, 12, 24, 36, and 60 months
Definite/Probable Stent thrombosis rates	1, 12, 24, 36, and 60 months	According to ARC-II classification
Target vessel myocardial infarction (TV-MI)	1, 12, 24, 36, and 60 months	Rates of individual components of the DoCE
Any stroke	1, 12, 24, 36, and 60 months	individual components of PoCE
Net adverse clinical events (NACE)	1, 12, 24, 36, and 60 months	Net adverse clinical events (NACE), define as POCE or BARC type 3 or 5 bleeding events
Patient-oriented composite endpoint (PoCE)	1, 12, 24, 36, and 60 months	Patient-oriented composite endpoint (PoCE) defined as all-cause death, any stroke, any MI, and any clinically and indicated revascularisation)
All-cause death	1, 12, 24, 36, and 60 months	individual components of PoCE
Any clinically and physiologically indicated revascularisation	1, 12, 24, 36, and 60 months
Target vessel failure (TVF)	1, 12, 24, 36, and 60 months	Target vessel failure, defined as cardiovascular death, TV MI and clinically-indicated target vessel revascularisation
BARC type 3 or 5 bleeding events	1, 12, 24, 36, and 60 months
BARC defined type 2, 3 or 5 bleeding events	1, 12, 24, 36, and 60 months
Device success	0 day (during index PCI)	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;
Procedure success during PCI	7 days	Device success + without the occurrence of DoCE + no stent thrombosis at discharge during the index procedure hospital stay (maximum of 7 days).
Clinically relevant ischemic or bleeding events	1, 12, 24, 36, and 60 months	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

Trial Locations

Locations (1)

Ling Tao; 🇨🇳 Xi'an, Shannxi, China