The efficacy and safety of paclitaxel-coated balloon in native small coronary arteries

The efficacy and safety of paclitaxel-coated Pantera® Lux drug-coated balloon catheter for treatment of lesions in native small coronary arteries: A prospective multi-center, observation registry, confirmatory clinical trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006493

Enrollment

100

Registered

2021-08-24

Start date

2022-01-20

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

None listed

Interventions

Procedure/Surgery : ?1) Percutaneous coronary intervention is performed in those with reference diameter between 2.25 to 2.75 mm. DCB (Pantera® Lux) inflation is done unless there is a flow-limiting c

balloon length should be 2-3 mm longer in both ends compared with standard balloon, nominal pressure for at least 30 seconds). DCBs should be delivered to target vessel within 2 minutes, should be inf

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients 19 years of age or older ? New coronary lesions of small vessel diameter (2.25 = diameter = 2.75 mm, length < 25 mm) ? When coronary intervention is required ? When written consent is possible

Exclusion criteria

Exclusion criteria: ? Allergic to paclitaxel ? Allergic to the coating material during balloon treatment ? During pregnancy or currently breast feeding ? Chronic total occlusive lesions ? Severe calcified lesions ? Patients with cardiogenic shock ? Lesions containing blood clots in blood vessels ? Patients with bleeding tendency ? Severe allergy to contrast agent ? Lesions that cannot be treated with interventional procedures ? Left ventricular ejection fraction less than 30% ? Left main coronary artery lesion ? Indications for coronary artery bypass surgery ? When unable to administer essential drugs

Design outcomes

Primary

Measure	Time frame
in-segment late lumen loss	—

Secondary

Measure	Time frame
restenosis rate;target lesion failure;DCB-related thrombosis	—

Countries

Korea, Republic of

Contacts

Public ContactJeongmi Lee

Gachon University Gil Medical Center

datex79@naver.com+82-32-460-3054

Outcome results