UMIN-CTR Clinical Trial

Public title

OptiCal frequency domain imaging-guided prospEctive AssessmeNt of severe calcified femoropopliteal lesions treated with DEBULKing device atherectomy

Acronym

OCEAN-DEBULK study

Scientific Title

OptiCal frequency domain imaging-guided prospEctive AssessmeNt of severe calcified femoropopliteal lesions treated with DEBULKing device atherectomy

Scientific Title:Acronym

OCEAN-DEBULK study

Region

Japan

Condition

Lower Extremity Artery Disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study was to exploratorily investigate factors associated with primary patency at 12 months after endovascular therapy in patients with lower extremity artery disease who had severely calcified stenotic or occlusive lesions in the femoropopliteal artery and were treated with debulking devices followed by drug coated balloon angioplasty under optical frequency domain imaging guidance, with a particular focus on the association between intraprocedural OFDI findings including the presence of calcified nodules and quantitative indices of calcification and postprocedural outcomes.

Basic objectives2

Others

Basic objectives -Others

To exploratorily investigate factors associated with primary patency at 24 months after treatment.

To exploratorily assess factors associated with the occurrence of distal embolization during the use of debulking devices, with a particular focus on their relationship with findings derived from optical frequency domain imaging.

To evaluate clinical outcomes and safety at 12 and 24 months after treatment, including restenosis, target lesion revascularization, target vessel revascularization, conversion to surgical revascularization, acute thrombotic occlusion, major lower limb amputation, and major adverse limb events.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Primary patency at 12 months after the treatment

Key secondary outcomes

1) Primary patency at 24 months
2) The following outcomes at 12 and 24 months:
1. Freedom from restenosis assessed by duplex ultrasound
2. Target Lesion Revascularization
3. Target Vessel Revascularization
4. Conversion to surgical revascularization
5. Occurrence of acute thrombotic occlusion
6. Major amputation (defined as amputation proximal to the ankle)
7. Major Adverse Limb Events
8. Rutherford classification
9. Initial procedural success rate
10. Incidence of adverse events: (1) All-cause mortality (2) Cardiovascular mortality (3) Stroke / Systemic embolism (4) Hospitalization for cardiac causes (5)Intracranial hemorrhage
3) Occurrence of distal embolization after debulking device treatment
1. True distal embolization (Angiographic distal embolization)
2. Clinically significant distal embolization (requiring additional treatment or causing symptoms)
3. Resolved distal embolization (improved by treatment or spontaneously)
4. Unresolved distal embolization

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with lower extremity artery disease who have severely calcified lesions in the femoropopliteal artery on angiography, defined as more than or equal to 70% diameter stenosis and classified as Peripheral Arterial Calcium Scoring System grade 3 or 4.
2) Patients who underwent elective endovascular therapy using debulking devices followed by drug-coated balloon angioplasty under optical frequency domain imaging guidance after the study approval date.
3) Patients aged 20 years or older at the time of informed consent.
4) Patients who are able to understand the treatment procedures and the objectives of the study and to provide written informed consent.

Key exclusion criteria

1) Patients with a life expectancy of less than 1 year due to terminal illness.
2) Patients with acute limb ischemia or acute thrombosis.
3) Patients with in-stent restenosis or occlusion lesions.
4) Patients with Rutherford Category 6, or critical limb ischemia with suspected extensive infection.
5) Patients with lesions at the anastomosis site after bypass surgery.
6) Patients unable to continue antiplatelet therapy (e.g., patients scheduled for surgery requiring withdrawal of antiplatelet agents within 1 month).
7) Patients who are pregnant, breastfeeding, or possibly pregnant.
8) Other patients judged inappropriate for enrollment by the principal investigator.

Target sample size

250

Name of lead principal investigator

1st name	Takayoshi
Middle name
Last name	Toba

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine, Department of Internal Medicine

Zip code

650-0017

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan

TEL

078-382-5846

Email

taka02222003@gmail.com

Name of contact person

1st name	Takayoshi
Middle name
Last name	Toba

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine, Department of Internal Medicine

Zip code

650-0017

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan

TEL

078-382-5846

Homepage URL

Email

taka02222003@gmail.com

Institute

Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine

Institute

Department

Personal name

Takayoshi Toba

Organization

Otehrs

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Kobe university hospital Clinical and Translational Research Center

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan

Tel

0783826669

Email

kansatsu@med.kobe-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪府済生会中津病院（大阪府）、大阪けいさつ病院（大阪府）、小倉記念病院（福岡県）、カレス記念病院（北海道）、済生会横浜市東部病院（神奈川県）、湘南鎌倉総合病院（神奈川県）、総合病院国保旭中央病院（千葉県）、大垣市民病院（岐阜県）、山形大学医学部附属病院（山形県）、昭和医科大学病院（東京都）、加古川中央市民病院（兵庫県）、甲南医療センター（兵庫県）、兵庫県立淡路医療センター（兵庫県）、はりま姫路総合医療センター（兵庫県）

Date of disclosure of the study information

2026

Year

03

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

250

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

Preinitiation

Date of protocol fixation

2026

Year

03

Month

31

Day

Date of IRB

Anticipated trial start date

2026

Year

05

Month

01

Day

Last follow-up date

2030

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

TBD

Registered date

2026

Year

02

Month

07

Day

Last modified on

2026

Year

02

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069115