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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

2272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2027-05-05

Brief Summary

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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).

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Detailed Description

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Conditions

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De Novo Stenosis Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Drug-coated balloon

Group Type EXPERIMENTAL

Paclitaxel coated balloon

Intervention Type DEVICE

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.

Drug-eluting stent

Group Type ACTIVE_COMPARATOR

Sirolimus eluting stents

Intervention Type DEVICE

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.

Interventions

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Paclitaxel coated balloon

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.

Intervention Type DEVICE

Sirolimus eluting stents

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.

Intervention Type DEVICE

Eligibility Criteria

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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

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No