UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044946 |
|---|---|
| Receipt number | R000051341 |
| Scientific Title | Prognosis of biodegradable peripheral vascular stent for iliac artery lesions: observational study |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2023/07/26 12:05:56 |
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Basic information
Public title
Prognosis of biodegradable peripheral vascular stent for iliac artery lesions: observational study
Acronym
Prognosis of biodegradable peripheral vascular stent for iliac artery lesions
Scientific Title
Prognosis of biodegradable peripheral vascular stent for iliac artery lesions: observational study
Scientific Title:Acronym
Prognosis of biodegradable peripheral vascular stent for iliac artery lesions
Region
| Japan |
Condition
Condition
Peripheral artery disease for iliac artery lesions
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze long-term data such as patency rate, complications, presence or absence of re-treatment, and prognosis, obtained by the KMP-001 study (UMIN000042238) in which biodegradable peripheral vascular stents were placed for iliac artery lesions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy/Safety outcomes up to 60 months after placement of biodegradable stents (adverse events, device complication, patency rate, presence or absence of re-treatment)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All cases enrolled in the KMP-001 at Keio University School of Medicine and other participating facilities are included.
Key exclusion criteria
Patients who have offered not to cooperate with this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | HIDEAKI |
| Middle name | |
| Last name | OBARA |
Organization
Keio University School of Medicine
Division name
Surgery
Zip code
1608582
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL
0333531211
obara.z3@keio.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Matsubara |
Organization
Keio University School of Medicine
Division name
Surgery
Zip code
1608582
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL
0333531211
Homepage URL
kmatsubaravs@gmail.com
Sponsor or person
Institute
Department of Surgery, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine, Ethics committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S1051044323001665?via%3Dihub
Publication of results
Partially published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1051044323001665?via%3Dihub
Number of participants that the trial has enrolled
100
Results
The 12 month primary patency rate was 88.6% (95% CI, 80.1% to 94.4%), which was lower than the prespecified standard. There were no device or procedure related deaths, major amputation, or distal embolization during the follow up period. The ankle brachial index maintained significant improvement through the 5 year period compared with that at baseline.
Results date posted
| 2023 | Year | 07 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This prospective, multicenter, single-arm clinical study evaluated 97 patients (97 lesions) with symptomatic TransAtlantic Inter-Society Consensus II A/B iliac artery lesions for 5 years after stent placement. The primary efficacy end point was 12-month primary patency compared with the prespecified standard derived from historical data with metallic stents, and the primary safety end point was the occurrence of major adverse clinical events within 5 years. All angiographic and computed tomography angiographic findings were evaluated by an independent core laboratory for quantitative vessel analysis.
Participant flow
The 12-month primary patency rate was 88.6% (95% CI, 80.1%-94.4%), which was lower than the prespecified standard. No significant difference was noted between the diameter stenosis at 9 and 12 months. There were no device- or procedure-related deaths, major amputation, or distal embolization during the follow-up period. The ankle-brachial index maintained significant improvement through the 5-year period compared with that at baseline. The Kaplan-Meier estimates of freedom from target lesion revascularization (TLR), major adverse cardiovascular events, and major adverse cardiovascular and limb events were 95.8%, 91.7%, and 87.5% at 12 months and 85.4%, 72.1%, and 62.5% at 5 years, respectively.
Adverse events
No specific device-related adverse events after device implantation.
Outcome measures
The 12 month primary patency rate was 88.6% (95% CI, 80.1% to 94.4%), which was lower than the prespecified standard. There were no device or procedure related deaths, major amputation, or distal embolization during the follow up period. The ankle brachial index maintained significant improvement through the 5 year period compared with that at baseline.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 09 | Month | 01 | Day |
Other
Other related information
This is a retrospective observational study that evaluates the efficacy and safety of long-term results for 60 months after a prospective, non-randomized, multicenter, open-label, single-arm study using the clinical trial device name "KMP-001 Biodegradable Peripheral Stent and Stent Delivery System".
Management information
Registered date
| 2021 | Year | 07 | Month | 24 | Day |
Last modified on
| 2023 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051341
