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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048227


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name