Clinical trial to evaluate efficacy and safety of KCS03 stent in a native coronary lesion

Clinical trial to evaluate efficacy and safety of KCS03 stent in a native coronary lesion - KCS03-1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010422

Enrollment

115

Registered

2013-04-08

Start date

2012-10-19

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

Stable angina, unstable angina and non-ST elevated myocardial infarction with de novo or restenotic coronary lesions

Interventions

Stent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Age 20 or over (2)Eligible for PCI (3)Evidence of stable angina or ischemic unstable angina or ischemic non-ST elevated myocardial infarction or silent ischemia (4)Eligible for CABG (5)Target lesion is located in a single native coronary artery. (6)Target lesion length is less than 28mm. (7)Reference vessel diameter is more than 3.0mm and less than 4.0mm. (8)Diameter stenosis of target lesion is more than 50%.

Exclusion criteria

Exclusion criteria: (1)Cardiogenic shock (2)After cardiopulmonary resuscitation (3)LVEF is less than 25% (4)Previous every DES implantation or scheduled DES implantation within 6 months against target vessel or side branches (5)Every PCI procedures within prior 30 days against coronary arteries (6)ST elevated myocardial infarction (7)Cerebral stroke or TIA within prior 30 days (8)Acute or chronic renal insufficiency (creatinine is more than 2.0mg/dL.) (9)Active gastric ulcer or active gastrointestinal bleeding (10)Life expectation is less than 12 months. (11)Non-target lesion requiring treatment is located in the target vessel or side branches of the target vessel. (12)Any lesions are located in LMT. (13)Target lesion is located in a bypass graft. (14)Target lesion is located in the ostium of the vessel. (15)Moderate or severe calcification is observed in target lesion or proximal side of target lesion.

Design outcomes

Primary

Measure	Time frame
TVF at 6 months	—

Secondary

Measure	Time frame
Technical success, procedural success, degree of stenosis immediately after the procedure, degree of stenosis (in-stent or in-segment) at 6 months, restenosis at 6 months, TLR at 6 months, TVR at 6 months, adverse events, stent thrombosis at 6 months, MACE at 6 months and length of hospital stay after the procedure	—

Countries

Japan

Contacts

Public ContactTakayuki Ohno

Kaneka Corporation Medical devices division

Takayuki.Ohno@kaneka.co.jp050-3133-7848

Outcome results

None listed

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