UMIN-CTR Clinical Trial

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
Email	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
Email	c.matsubara@kyoto-mp.co.jp

Sponsor
Institute	KYOTO MEDICAL PLANNING Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048227