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EaRly and long-tErm veSsel healing afTer implantatiOn of duRable polymer DES and bioabsorbable polymer DES: imaging analysis by OCT and coronary angioscopy (RESTORE registry)

EaRly and long-tErm veSsel healing afTer implantatiOn of duRable polymer DES and bioabsorbable polymer DES: imaging analysis by OCT and coronary angioscopy (RESTORE registry) - RESTORE registry

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000033009
Enrollment
150
Registered
2018-06-15
Start date
2016-02-01
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

Ischemic heart disease

Interventions

None listed

Sponsors

Department of Cardiology, Osaka Police Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Any PCI indication for native coronary lesions satisfying the following criteria 1. PCI indication for any clinical presentation including stable and unstable angina, silent myocardial ischemia, non-ST elevation and ST elevation myocardial infarction. 2. Subject is appropriate to be treated by PCI according to the local practice. 3. Patient is at least 20 years of age. 4. Signed informed consent. 5. The patient understands and accepts clinical follow-up. Angiographic: 1. Patients with angiographically significant stenosis in de novo, native, previously unstinted lesions, which is in operator's opinion appropriate to be treated by PCI. 2.Significant stenosis was defined as 90% or greater stenosis of a major epicardial vessel or proof of functional ischemic test. 3. Patients with angiographically significant stenosis, which is in operator's opinion related to symptoms of angina.

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity or contraindication to aspirin, clopidogrel, prasugrel, cobalt chromium, platinum chromium, everolimus, sirolimus, or a sensitivity to contrast media, which cannot be adequately pre-medicated 2. Participation in another clinical trial (up to 12 months after index procedure) 3. Patients with a life expectancy of < 2 year

Design outcomes

Primary

MeasureTime frame
1. Neointimal coverage grade on coronary angioscopy 3 and 24 months after stent implantation 2. Light property on optical coherence tomography 3 and 24 months after stent implantation

Countries

Japan

Contacts

Public ContactYohei Sotomi

Osaka Police Hospital Department of Cardiology

sotomiyohei@gmail.com0667716051

Outcome results

None listed

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