Debulking with Rotational atherectomy versus Balloon Angioplasty In Patients with In-stent Restenosis

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0002913

Enrollment

140

Registered

2018-06-04

Start date

2018-05-08

Completion date

Unknown

Last updated

2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : Rotational atherectomy followed by balloon angioplasty vs Balloon angioplasty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men or women at least 19 years of age Subjects with coronary ISR 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

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.

Design outcomes

Primary

Measure	Time frame
Angiography-measured in-segment minimal lumen area	—

Secondary

Measure	Time frame
Device success rate;Angiographic outcomes immediate after procedure;OCT outcomes immediate after procedure : In-segment minimal lumen area loss;OCT outcomes immediate after procedure : In-stent minimal lumen area loss;OCT outcomes immediate after procedure : In-segment neointimal volume;OCT outcomes immediate after procedure : In-stent neointimal volume;Angiographic outcomes : In-segment late lumen loss;Angiographic outcomes : In-stent late lumen loss;Angiographic outcomes : In-segment minimal lumen diameter;Angiographic outcomes : In-stent minimal lumen diameter;Angiographic outcomes : In-segment diameter stenosis;Angiographic outcomes : In-stent diameter stenosis;OCT outcomes : in-segment late lumen area loss;OCT outcomes : in-stent late lumen area loss;composite event rate ; 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.	—

Measure

Time frame

Device success rate;Angiographic outcomes immediate after procedure;OCT outcomes immediate after procedure : In-segment minimal lumen area loss;OCT outcomes immediate after procedure : In-stent minimal lumen area loss;OCT outcomes immediate after procedure : In-segment neointimal volume;OCT outcomes immediate after procedure : In-stent neointimal volume;Angiographic outcomes : In-segment late lumen loss;Angiographic outcomes : In-stent late lumen loss;Angiographic outcomes : In-segment minimal lumen diameter;Angiographic outcomes : In-stent minimal lumen diameter;Angiographic outcomes : In-segment diameter stenosis;Angiographic outcomes : In-stent diameter stenosis;OCT outcomes : in-segment late lumen area loss;OCT outcomes : in-stent late lumen area loss;composite event rate ; 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.

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Countries

Korea, Republic of

Contacts

Public ContactDo-yoon Kang

Asan Medical Center

Outcome results