UMIN-CTR Clinical Trial

Public title

IntraVascular UltrasOund SuppoRted Endovascular Therapy in Superficial Femoral ArterY Disease Prospective multicenter registry

Acronym

IntraVascular UltrasOund SuppoRted Endovascular Therapy in Superficial Femoral ArterY Disease Prospective multicenter registry: (IVORY)

Scientific Title

IntraVascular UltrasOund SuppoRted Endovascular Therapy in Superficial Femoral ArterY Disease Prospective multicenter registry

Scientific Title:Acronym

IntraVascular UltrasOund SuppoRted Endovascular Therapy in Superficial Femoral ArterY Disease Prospective multicenter registry: (IVORY)

Region

Japan

Asia(except Japan)

Condition

PAD: peripheral artery disease

Classification by specialty

Cardiology

Vascular surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this research is to prospectively investigate the 12-month-safety and efficacy of intravascular ultrasound (IVUS) supported endovascular therapy (EVT) in patients with symptomatic peripheral artery disease (PAD) with a femoro-popliteal artery (FPA) lesion.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Twelve-month restenosis rate (Definition of restenosis;50% or more stenosis found on angiography or CTA, less than 2.4 PSVR found on duplex ultrasound)
Restenosis is basically evaluated by duplex 12 plus or minus months after endovascular procedure.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patient has signed and dated the informed consent.
2) Patient has symptoms of atherosclerotic peripheral arterial disease classified as Rutherford Category1,,2, 3, 4 or 5.
3) Patient has a resting ABI less than 0.9 or an abnormal exercise ABI if resting ABI is normal. Patient with incompressible arteries (ABI greater than 1.2) must have a TBI less than 0.8.
4) Patient has a de novo or restenotic lesion with greater 50% stenosis documented angiographically in the target lesion.
5) Patient agrees to return for a clinical status assessment and duplex ultrasound post-procedure at 12 months.

Key exclusion criteria

1) Patient is under 18 years of age.
2) Patient is pregnant or breast-feeding.
3) Patient has significant stenosis (> 50%) or occlusion of inflow tract (proximal ipsilateral, iliofemoral, or aortic lesions) not successfully treated before this procedure (success is measured as smaller than 30% residual stenosis).
4) Patient has undergone an unsuccessful arterial interventional treatment of the legs (i.e., the treatment resulted in greater than 30% residual stenosis of a treated lesion) within 30 days prior to the study procedure.
5) Patient has any planned surgical or interventional procedure within 30 days after the study procedure.
6) Patient has a medical condition or disorder that would limit life expectancy to less than 1 year.
7) Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, or nitinol that, in the opinion of the investigator, cannot be adequately premedicated.
8) Patient has untreated angiographically-evident thrombus in the target lesion.
9) Patient has a bypass graft with an anastomosis in the target vessel.

Target sample size

2000

Name of lead principal investigator

1st name
Middle name
Last name	Osamu Iida

Organization

Japan Labour Health and Welfare
Organization,
Kansai Rosai Hospital

Division name

Department of Cardiovascular Medicine

Zip code

Address

3-1-69 Inabaso, Amagasaki-shi, 660-3511 Japan

TEL

06-6416-1221

Email

iida.osa@gmail.com

Name of contact person

1st name
Middle name
Last name	Osamu Iida

Organization

Japan Labour Health and Welfare Organization, Kansai Rosai Hospital

Division name

Department of Cardiovascular Medicine

Zip code

Address

3-1-69 Inabaso, Amagasaki-shi, 660-3511 Japan

TEL

06-6416-1221

Homepage URL

Email

iida.osa@gmail.com

Institute

IVORY

Institute

Department

Personal name

Organization

NONE

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

01

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Open public recruiting

Date of protocol fixation

2015

Year

09

Month

07

Day

Date of IRB

Anticipated trial start date

2015

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

01

Month

07

Day

Last modified on

2016

Year

02

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021904