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Completed

NCT Number: NCT04766749

Remote Ischemic Preconditioning on the Prognosis of Patients With Elective PCI Using Drug-coated Balloon

Drug-coated balloon is being used more and more widely for the advantage of intervention without implantation.

But the balloon needs to be released long enough to be effective. Prolonged balloon dilation resulting in the cessation of blood flow in the distal vessels, especially large vessels, may result in severe ischemia in the patient.

RIPC can enhance patients' tolerance to ischemic events, so we believe that RIPC application before the use of drug balloon for PCI can improve patients' ischemic symptoms, thus increasing the release time of drug balloon and improving the effect.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai central China cardiovascular Hospital

Zhengzhou, Henan, China

About this study

Some patients receiving PCI cannot tolerate the symptoms of myocardial ischemia caused by the release of the drug balloon for a long time and even lead to the occurrence of adverse events.RIPC was found to improve tolerance to myocardial ischemia in patients.

At the same time, it can open collateral circulation and improve the tolerance of myocardial ischemia in patients.Therefore, this study designed a parallel control group. The experimental group was treated with RIPC before PCI, while the control group was not treated before PCI.

The operator does not know whether the patient has undergone RIPC or not, and the operator decides the time of drug balloon release according to the symptoms of the patient during the operation.Angiography was performed at 6 months, and QCA was used to determine late lumen loss at 1 year.The 1-year incidence of target lesion failure events was assessed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diameter stenosis>=50% by visual estimation intend to undergo drug-coated balloon implantation
  • Target vessel diameter> 2.5mm

Exclusion criteria

  • Chronic Total Obstructive lesion
  • Diagnose patients with acute myocardial infarction <24 hours
  • Can't tolerate or not suitable for RIPC
  • Severe hepatic and renal insufficiency
  • Expected survival <1 year
  • Severe calcification needing rotational atherectomy
  • Intolerable to dual antiplatelet therapy

Treatment and study plan

RIPC

Other

RIPC is delivered with a standard blood pressure cuff placed on the upper thigh. The cuffs are inflated to 200 mm Hg and keep inflated for 5 minutes,Then deflated to 0 mmHg and keep uninflated for 5 minutes, This cycle is repeated four times

Primary outcomes

  1. TLF

    Time frame: 12 months

    TLF, a composite of cardiac death, target vessel-related myocardial infarction (MI; not clearly attributed to a nontarget vessel and excluding periprocedural MI), or clinically indicated target lesion revascularization (TLR)

Secondary outcomes

  1. Late lumen loss of target vessel（mm）

    Time frame: 6 months

    Late Lumen Loss of target vessel（mm） by Quantitative Coronary Angiography (QCA).

  2. DCB expansion time

    Time frame: less than 120 seconds (On the 1 day of PCI)

    We hypothesis/speculated that the RIPC group had better ischemia tolerance, so the balloon dilation time was longer than the control group.

    But the total time for all patients is less than 120 seconds

Sponsors and collaborators

Lead sponsor

Henan Institute of Cardiovascular Epidemiology

Other

Registry information

Acronym: RIPC-DCB

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 23, 2021
Registry last updated
Dec 7, 2023

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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