UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042238 |
|---|---|
| Receipt number | R000048227 |
| Scientific Title | Efficacy and Safety Evaluation of Biodegradable Peripheral Stent for Iliac Artery Lesions |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2020/10/26 14:41:41 |
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Basic information
Public title
Efficacy and Safety Evaluation of Biodegradable Peripheral Stent for Iliac Artery Lesions
Acronym
KMP-001 Trial
Scientific Title
Efficacy and Safety Evaluation of Biodegradable Peripheral Stent for Iliac Artery Lesions
Scientific Title:Acronym
KMP-001 Trial
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 evaluate the efficacy and safety of endovascular treatment using a biodegradable peripheral stent for patients with lesions of the common iliac artery or external iliac artery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary patency rate at 12 months after stent implantation
Key secondary outcomes
Efficacy Outcomes
1. Successful passage through the lesion of the device, its successful implantation in the intended target lesion, and the residual stenosis rate <30% (Acute procedural success).
2. Assisted primary patency rate and secondary patency rate 12 months after stent implantation.
3. WIQ (Walking Impairment Questionnaire) score.
4. Rutherford classification.
Safety Outcomes
1. Adverse events
2. Failure of the clinical trial equipment
3. Procedural success rate at repeated operation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Biodegradable peripheral stent
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
1. Patient is 20 years old or older, regardless of gender.
2. Written consent is obtained from the patient (in cases that it is difficult to obtain consent from the person who is to be the subject, consent from the person who is to be the alternate must be obtained).
3. Patient with intermittent claudication or resting pain that limits their daily activities.
4. Patient who is eligible for 60 months follow-up and is able to comply with the follow-up requirements.
5. Patient with lesions in the common or external iliac artery.
6. Patient with significant de novo stenotic lesions with stenosis rate >= 70% or with suboptimal percutaneous transluminal angioplasty (PTA) (residual stenosis > 50%, recoil, dissection, intimal flap, etc.)
7. Patient with A or B lesion in TASC II classification (one lesion per limb per patient is registered). (In case of bilateral lesions, the second lesion should be treated 30 days after the first implantation.).
The same day intervention is allowed if the ipsilateral SFA (superficial femoral artery area) is involved.
8. Patient with resting ABI or post-exercise. ABI of 0.9 or less.
9. Patient with a target lesion stenosis length of 70 mm or less measured by angiography using a radiopaque ruler or IVUS (Intravascular Ultrasound).
10. Target vessel reference diameters is >= 5.0 mm and <= 9.0 mm.
Key exclusion criteria
1. Patient on dialysis or immunosuppressive therapy.
2. Patient with severe renal failure (serum creatinine > 2.0 mg/dL).
3. Patient who is allergic to drugs used for catheter treatment and examination (contrast agents, heparin, thienopyridine, aspirin, etc.).
4. Patient for whom antiplatelet and/or antithrombotic therapy is not available.
5. Patient on ongoing steroid hormone therapy.
(ointments, creams due to skin diseases, eye drops, etc, and steroids during asthma attacks are allowed.)
6. Patient who requires debulking due to severe Calcification or other diseases.
7. Patient who has underwent stent implantation or surgical treatment within 10 mm distal / proximal from the target lesion.
8. Patient with in-stent restenosis.
9. Patient who developed myocardial infarction/cerebrovascular injury within 30 days before treatment.
10. Patient with acute or subacute obstruction at
the target lesion.
11. Patient with hemorrhagic disease within the past 3 months.
12. Patient with aneurysms in abdominal aorta, iliac artery or other arteries.
13. (Possibly) pregnant women.
14. Patient who is not expected to live more than 12 months.
15. Patient who is enrolled in another clinical trial. In case that the patient has completed all the follow-ups in that study, he/she is eligible for this study.
16. Ineligible patient judged by PI (principal investigator) or other investigator .
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Yamada |
Organization
KYOTO MEDICAL PLANNING Co., Ltd.
Division name
R & D Division
Zip code
607-8035
Address
4 Kanda-cho, Shinomiya, Yamashina-ku, Kyoto City, Kyoto
TEL
075-594-5598
h.yamada@kyoto-mp.co.jp
Public contact
Name of contact person
| 1st name | Chisa |
| Middle name | |
| Last name | Matsubara |
Organization
KYOTO MEDICAL PLANNING Co., Ltd.
Division name
R & D Division
Zip code
607-8035
Address
4 Kanda-cho, Shinomiya, Yamashina-ku, Kyoto City, Kyoto
TEL
075-594-5598
Homepage URL
c.matsubara@kyoto-mp.co.jp
Sponsor or person
Institute
KYOTO MEDICAL PLANNING Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
KYOTO MEDICAL PLANNING Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
| 2020 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 26 | Day |
Last modified on
| 2020 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048227
