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NCT Number: NCT04561739

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

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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Key information

Conditions

De Novo Stenosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ling Tao

Xi'an, Shannxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with an indication for PCI due to acute or chronic coronary syndrome
  • Patients with de-novo, non-complex lesion* and underwent successful pre-dilation**
  • Patients who are able to complete the follow-up and compliant to the prescribed medication
  • Non-complex PCI is defined as
  • 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

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

Exclusion criteria

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

Treatment and study plan

Paclitaxel coated balloon

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.

Sirolimus eluting stents

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.

Primary outcomes

  1. Device-oriented Composite Endpoint (DoCE)

    Time frame: 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 outcomes

  1. Device-oriented Composite Endpoint (DoCE)

    Time frame: 1, 12, 36, and 60 months

    Rates of the DoCE beside the time point of primary endpoint

  2. Cardiac cause death

    Time frame: 1, 12, 24, 36, and 60 months

    Rates of individual components of the DoCE

  3. Target vessel myocardial infarction (TV-MI)

    Time frame: 1, 12, 24, 36, and 60 months

    Rates of individual components of the DoCE

  4. Clinically and physiologically indicated target lesion revascularization (CI-TLR)

    Time frame: 1, 12, 24, 36, and 60 months

    Rates of individual components of the DoCE

  5. Patient-oriented composite endpoint (PoCE)

    Time frame: 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)

  6. All-cause death

    Time frame: 1, 12, 24, 36, and 60 months

    individual components of PoCE

  7. Any MI

    Time frame: 1, 12, 24, 36, and 60 months

    individual components of PoCE

  8. Any stroke

    Time frame: 1, 12, 24, 36, and 60 months

    individual components of PoCE

  9. Any revascularisation

    Time frame: 1, 12, 24, 36, and 60 months

    individual components of PoCE

  10. Any clinically and physiologically indicated revascularisation

    Time frame: 1, 12, 24, 36, and 60 months

  11. Target vessel failure (TVF)

    Time frame: 1, 12, 24, 36, and 60 months

    Target vessel failure, defined as cardiovascular death, TV MI and clinically-indicated target vessel revascularisation

  12. Clinical and physiologically indicated target vessel revascularization

    Time frame: 1, 12, 24, 36, and 60 months

  13. Net adverse clinical events (NACE)

    Time frame: 1, 12, 24, 36, and 60 months

    Net adverse clinical events (NACE), define as POCE or BARC type 3 or 5 bleeding events

  14. BARC type 3 or 5 bleeding events

    Time frame: 1, 12, 24, 36, and 60 months

  15. BARC defined type 2, 3 or 5 bleeding events

    Time frame: 1, 12, 24, 36, and 60 months

  16. Definite/Probable Stent thrombosis rates

    Time frame: 1, 12, 24, 36, and 60 months

    According to ARC-II classification

  17. Device success

    Time frame: 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;

  18. Procedure success during PCI

    Time frame: 7 days

    Device success + without the occurrence of DoCE + no stent thrombosis at discharge during the index procedure hospital stay (maximum of 7 days).

  19. Clinically relevant ischemic or bleeding events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

Paclitaxel-coated Balloon for the Treatment of De-novo Non-complex Coronary Artery Lesions: an Open-label, Multicentre, Randomised, Non-inferiority Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2027
First posted
Sep 24, 2020
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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