Rotational atherectomy and Wolverine cutting balloon angioplasty prior to Agent drug-coated balloon application in calcified coronary lesions

Rotational atherectomy and Wolverine cutting balloon angioplasty prior to Agent drug-coated balloon application in calcified coronary lesions - Rotaverigent study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000051470

Enrollment

100

Registered

2023-07-01

Start date

2023-07-01

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 atherosclerosis

Interventions

Combined lesion preparation using rotational atherectomy and consecutive cutting balloon angioplasty, followed by drug-coated balloon application in calcified coronary lesions.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Moderate to severe calcified coronary stenotic lesions

Exclusion criteria

Exclusion criteria: 1) Cardiogenic shock or hemodynamic instability 2) Myocardial infarction within 7 days 3) Reference vessel diameter < 2.0 mm 4) In-stent restenoses 5) Women of childbearing potential 6) Other conditions judged inappropriate

Design outcomes

Primary

Measure	Time frame
Primary patency (free ratio from target lesion revascularization)	—

Secondary

Measure	Time frame
1) late lumen loss assesed by follow-up angiography 2) lale luminal area loss assesed by follow-up intravascular ultrasound examination	—

Countries

Japan

Contacts

Public ContactKazunori Terashita

Shiroyama hospital Cardiovascular center

k-terashita@shiroyama-hsp.or.jp+81-72-958-1000

Outcome results

None listed

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