Unique ID issued by UMIN | UMIN000037284 |
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Receipt number | R000042487 |
Scientific Title | Randomized controlled trial of Percutaneous Coronary Intervention for Calcified Lesions with Diamondback Versus Rotablator guided by Optical Coherence Tomography |
Date of disclosure of the study information | 2019/07/05 |
Last modified on | 2023/12/09 13:37:23 |
Randomized controlled trial of Percutaneous Coronary Intervention for Calcified Lesions with Diamondback Versus Rotablator guided by Optical Coherence Tomography
DIRO trial
Randomized controlled trial of Percutaneous Coronary Intervention for Calcified Lesions with Diamondback Versus Rotablator guided by Optical Coherence Tomography
DIRO trial
Japan |
Coronary Artery Disease
Cardiology |
Others
NO
To investigate safety and efficacy of percutaneous coronary intervention with Diamondback for calcified lesions guided by optical coherence tomography compared to Rotablator.
Safety,Efficacy
Tissue modification and stent outcomes assessed by OCT.
Procedural complications (coronary artery perforation, slow/no flow, dissections during procedure and peri-procedural myocardial infarction) and procedural time and contrast volume. Major adverse cardiovascular events at 8 months after the procedure
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
2
Treatment
Device,equipment |
Patients treated with diamondback
Patients treated with rotablator
18 | years-old | < |
Not applicable |
Male and Female
1) All patients should be over 18 years of age.
2) Patients with stable coronary artery disease must have a clinical indication for percutaneous coronary intervention.
3) The target lesion must be a de novo calcified lesion that has calcification more than 180 degree of arc assessed by OCT.
4) Moderate or severe calcification by angiogram, if OCT does not cross the lesion.
1)Ostial left main artery or ostial right coronary artery lesions.
2)Female patients of childbearing potential.
3)Life expectancy less than 12 months.
100
1st name | Masami |
Middle name | |
Last name | Nishino |
Osaka Rosai Hospital
Cardiology
5918025
1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, Japan
072-252-3561
mnishino@osakah.johas.go.jp
1st name | Naotaka |
Middle name | |
Last name | Okamoto |
Osaka Rosai Hospital
Cardiology
5918025
1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, Japan
072-252-3561
okamo10nao@osakah.johas.go.jp
Osaka Rosai Hospital, Cardiology
None.
Self funding
Osaka Rosai Hospital
1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, Japan
072-252-3561
okamo10nao@osakah.johas.go.jp
NO
2019 | Year | 07 | Month | 05 | Day |
https://www.jacc.org/doi/10.1016/j.jcin.2023.06.016
Published
https://www.jacc.org/doi/10.1016/j.jcin.2023.06.016
100
The stent expansion was significantly greater in the RA group vs the OA group (99.5% vs 90.6%; P = 0.02). The maximum atherectomy area was significantly larger in the RA group than in the OA group (1.34 [IQR: 1.02-1.89] mm2 vs 0.83 [IQR: 0.59-1.11] mm2; P = 0.004). The procedural outcomes and clinical events at 8 months did not differ between the groups. The vascular healing was sufficient in both groups.
2023 | Year | 12 | Month | 09 | Day |
There was no significant difference between the 2 groups regarding the age, sex, coronary risk factors, and past medical history. The ejection fraction assessed byechocardiography was similar. The laboratory data including the low-density lipoprotein cholesterol, glycosylated hemoglobin, hemoglobin, creatinine, and NT-pro BNP were also comparable.
Patients were recruited from all patients scheduled to undergo PCI in our institution between August 2019 and October 2021. Eligible patients were randomly allocated 1:1 to a lesion preparation with RA vs OA.
One patient had a coronary perforation after the OA. No one had a tamponade and death during the procedure.
The stent expansion was significantly greater in the RA group vs the OA group (99.5% vs 90.6%; P = 0.02). The maximum atherectomy area was significantly larger in the RA group than in the OA group (1.34 [IQR: 1.02-1.89] mm2 vs 0.83 [IQR: 0.59-1.11] mm2; P = 0.004). The procedural outcomes and clinical events at 8 months did not differ between the groups. The vascular healing was sufficient in both groups.
Completed
2019 | Year | 07 | Month | 05 | Day |
2019 | Year | 08 | Month | 09 | Day |
2019 | Year | 07 | Month | 05 | Day |
2022 | Year | 06 | Month | 30 | Day |
2019 | Year | 07 | Month | 05 | Day |
2023 | Year | 12 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042487
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