Comparison of the Incidence of Slow Flow Following Rotational Atherectomy to Severely Calcified Coronary Artery Lesions between Short Single Session Versus Long Single Session: A Randomized Controlled Trial.

Comparison of the Incidence of Slow Flow Following Rotational Atherectomy to Severely Calcified Coronary Artery Lesions between Short Single Session Versus Long Single Session: A Randomized Controlled Trial. - ROTASOLO trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000047231

Enrollment

300

Registered

2022-03-25

Start date

2022-04-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Coronary Artery Disease

Interventions

short single session (up to 15 seconds) long single session (20 to 30 seconds)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with ischemic heart disease who undergo percutaneous coronary intervention using rotational atherectomy. 2. Patients who gave written informed consent. 3. Angiographically severe calcification in target lesions. 4. Intravascular imaging shows over 180 degree superficial calcification/calcified nodule, intravascular imaging devices cannot cross the lesion due to severe stenosis, or intravascular imaging device (typically optical coherent tomography) cannot provide valid images due to severe stenosis.

Exclusion criteria

Exclusion criteria: 1. Less than 20 years-old. 2. Contraindication in instructions-for-use of Rotablator.

Design outcomes

Primary

Measure	Time frame
Slow flow just following rotational atherectomy. Slow flow is defined as [(initial TIMI-frame count)x1.1 minus (TIMI frame count just after rotational atherectomy) ] less than 0. Absence of slow flow is defined as [(initial TIMI-frame count)x1.1 minus (TIMI frame count just after rotational atherectomy) ] not lower than 0. If >/=2 burrs are used for rotational atherectomy, slow flow will be evaluated only after the initial burr cross the lesion. Once initial burr crosses the lesion, slow flow will not be evaluated for this study after the second burr cross the lesion. If initial burr cannot cross the lesion and the second burr (typically smaller burr) cross the lesion, slow flow will be evaluated for this study after the second burr cross the lesion. If halfway rotational atherectomy is performed, slow flow will be evaluated just after halfway rotational atherectomy.	—

Measure

Time frame

Slow flow just following rotational atherectomy. Slow flow is defined as [(initial TIMI-frame count)x1.1 minus (TIMI frame count just after rotational atherectomy) ] less than 0. Absence of slow flow is defined as [(initial TIMI-frame count)x1.1 minus (TIMI frame count just after rotational atherectomy) ] not lower than 0. If >/=2 burrs are used for rotational atherectomy, slow flow will be evaluated only after the initial burr cross the lesion. Once initial burr crosses the lesion, slow flow will not be evaluated for this study after the second burr cross the lesion. If initial burr cannot cross the lesion and the second burr (typically smaller burr) cross the lesion, slow flow will be evaluated for this study after the second burr cross the lesion. If halfway rotational atherectomy is performed, slow flow will be evaluated just after halfway rotational atherectomy.

—

Secondary

Measure	Time frame
Periprocedural myocardial infarction. Complications such as vessel perforation.	—

Countries

Japan

Contacts

Public ContactKenichi Sakakura

Saitama Medical Center, Jichi Medical University Division of Cardiovascular Medicine

ksakakura@jichi.ac.jp048-647-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026