Skip to main content
OpenTrials
Completed

NCT Number: NCT03401203

Debulking With Rotational Atherectomy Versus Balloon Angioplasty In Patients With In-stent Restenosis

This study is to establish the primary hypothesis that debulking with rotational atherectomy (RA) followed by balloon angioplasty (BA) is superior to BA alone for lesion preparation in patients with coronary in-stent restenosis (ISR) regarding angiography-measured in-segment minimal lumen area at 1 year.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Vessels

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soon Chun Hyang University Hospital Bucheon, Bucheon-si, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men or women at least 19 years of age
  • Subjects with coronary In-stent restenosis planned revascularization
  • In-stent restenosis with neointimal hyperplasia evaluated by intravascular imaging
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion criteria

  • Complex lesion anatomy that disables rotational atherectomy
  • Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
  • Life expectancy < 1 years for any non-cardiac or cardiac causes
  • Unwillingness or inability to comply with the procedures described in this protocol.

Treatment and study plan

Rotational atherectomy followed by balloon angioplasty

Procedure

Percutaneous coronary intervention

Balloon angioplasty

Procedure

Percutaneous coronary intervention

Primary outcomes

  1. In-segment minimal lumen diameter on angiographic

    Time frame: 1 year

Secondary outcomes

  1. Device success rate

    Time frame: 1 year

  2. Angiographic outcomes immediate after procedure

    Time frame: 1 hour

    In-segment and in-stent minimal lumen diameter and diameter stenosis

  3. OCT outcomes immediate after procedure : In-segment and in-stent minimal lumen area

    Time frame: 1 hour

  4. OCT outcomes immediate after procedure : In-segment and in-stent neointimal volume

    Time frame: 1 hour

  5. Angiographic outcomes : In-segment and in-stent late loss, diameter stenosis

    Time frame: 1 year

  6. OCT outcomes : in-segment and in-stent late lumen area, minimal lumen area loss

    Time frame: 1 year

  7. composite event rate

    Time frame: 1 year

    A composite event of following factors is defined as the occurrence of any event from these events and denoted that event as the union of these.

    • Death (cardiac, vascular, non-cardiovascular)
    • Myocardial infarction (periprocedural, spontaneous)
    • Stent thrombosis (definite/probable)
    • Stroke
    • Any revascularization
    • Target lesion revascularization (TLR)
    • Target vessel revascularization (TVR)
    • Clinically significant bleeding (BARC type 2,3,4,5)
    • Target lesion failure (cardiac death, target vessel MI or ischemia-driven TLR)
    • Target vessel failure (cardiac death, target vessel MI or ischemia-driven TVR)
    • A composite of all-cause death, MI, any repeat revascularization
    • A composite of cardiac death, target vessel MI, stroke, or clinically significant bleeding (Bleeding Academic Research Consortium (BARC) type 2,3,4,5)

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

A Prospective, Open Label, Multi-center, Dual Arm, Randomized Trial : The ROTA-ISR (Debulking With Rotational Atherectomy Versus Balloon Angioplasty In Patients With In-stent Restenosis) Trial

Acronym: ROTA-ISR

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 17, 2018
Registry last updated
Jan 4, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.