Prospective, Single center, Registry to Evaluate the Long-term Clinical Safety and Efficacy of the Resolute Integrity drug eluting stent in an all-comers population.

Prospective, Single center, Registry to Evaluate the Long-term Clinical Safety and Efficacy of the Resolute Integrity drug eluting stent in an all-comers population. - Resolute Integrity-KUKI Registry

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009909

Enrollment

1000

Registered

2013-01-31

Start date

2012-10-09

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 (CAD)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients aged 20 years or older 2.Patients with symptomatic coronary disease 3.Patients with a clinical indication for PCI and stenting of at least one coronary lesion, visually confirmed on coronary angiography 4.Patients who give informed consent to participate in this clinical study and sign the informed consent form approved by the institutional review board of each study site before the index PCI 5.Patients who agree to undergo all clinical follow-up procedures specified in the protocol for this clinical study

Exclusion criteria

Exclusion criteria: 1.Patients with cardiogenic shock 2.Patients who are pregnant or possibly pregnant 3.Patients who cannot comply with the antiplatelet therapy specified for this clinical study 4.Patients scheduled to undergo elective surgery within 6 months post-index PCI 5.Patients with a history of allergic reaction or hypersensitivity to zotarolimus, sirolimus, tacrolimus, everolimus, or other analogues or derivatives 6.Patients with an allergic reaction to antiplatelet or anticoagulant drugs, such as heparin, aspirin, ticlopidine, or clopidogrel, or contrast agents, or those who cannot tolerate these substances and to whom appropriate treatments cannot be given 7. Patient who underwent stent treatment with BMS in other lesions within 6 months prior to the conduct of index PCI of the target vessel

Design outcomes

Primary

Measure	Time frame
Cumulative incidence of target lesion failure at 12 months after index PCI.	—

Secondary

Measure	Time frame
1. Cumulative incidence of stent fracture by angiographic assessment at 12, 24 and 36 months after index PCI. 2. Cumulative incidence of stent thrombosis at 12, 24 and 36 months after index PCI. 3. Cumulative incidence of peri-stent contrast staining by angiographic assessment at 12, 24 and 36 months after index PCI. 4. Cumulative incidence of target vessel failure at 12, 24 and 36 months after index PCI in DM patients.	—

Measure

Time frame

1. Cumulative incidence of stent fracture by angiographic assessment at 12, 24 and 36 months after index PCI. 2. Cumulative incidence of stent thrombosis at 12, 24 and 36 months after index PCI. 3. Cumulative incidence of peri-stent contrast staining by angiographic assessment at 12, 24 and 36 months after index PCI. 4. Cumulative incidence of target vessel failure at 12, 24 and 36 months after index PCI in DM patients.

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Countries

Japan

Contacts

Public ContactYasutaka Shirasaki

Kuki General Hospital Cardiovascular Internal Medicine

0480-26-0033

Outcome results