Stent-less Treatment Strategy for acute coronary syndrome

JRCT ID: jRCTs032240139

Registered date:04/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute coronary syndrome
• Date of first enrollment: 05/12/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Combined treatment with scoring balloon and drug-coated balloon

Outcome(s)

• Primary Outcome: Percentage of successful treatment without stenting by interventional treatment

Secondary Outcome

- Quantitative flow ratio value at the end of PCI
- Minimum lumen area
- Degree of dissection
- Quantitative angiography
- Major cardiovascular events within 30 days of PCI

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with acute coronary syndrome who achieved reperfusion of TIMI flow grader than or equal to 2 of the target lesion before or during intracoronary imaging-guided PCI
2) Patients with no significant dissection before enrollment: defined as dissection with no hematoma or media injury with circumferential extent of dissection less than 180 degrees, and no progression over a 15-minute course
3) Patients scheduled for treatment with DES or DCB
4) Patients with a lesions that is expected to be treatable with a single DCB (lesion length less than 30 mm)
5) Patients who are 20 years of age or older at the time consent is obtained
6) Patients whose written consent has been obtained
7) Patients with no disturbance of consciousness (Japan Coma Scale 0)
8) Patients with no history of dementia

Exclude criteria

1) Patients whose life expectancy is expected to be less than 1 year
2) Patients with cardiogenic shock at the time of PCI
3) Patients with stent thrombosis lesions or in-stent restenosis lesions
4) Patients with chronic total occlusion lesions, left main trunk lesions, bypass graft lesions, or heavily calcified lesions
5) Female patients who are pregnant or planning to become pregnant or who are breastfeeding
6) Patients allergic to paclitaxel and iopromide
7) Patients allergic to contrast media
8) Patients with severe renal dysfunction (eGFR of less than 30 ml per min per 1.73m2) or dialysis
9) Patients with lesions with a vessel diameter greater than 4.5 mm
10) Patients who are deemed inappropriate as subjects by the principal investigator or subinvestigator
11) Patients participating in the other clinical trials or clinical studies
12) Patients with allergies or adverse reactions to antithrombotic drugs
13) Patients who do not receive a clear response about their participation

Related Information

• Primary Sponsor: Hibi Kiyoshi
• Source(s) of Monetary Support: Research funding