Peripheral Arterial DiseaseNCT02169921
TurboHawk™ Japan Trial in Patients With PAD
A study testing Atherectomy Catheter in people with Peripheral Arterial Disease, run by Medtronic Endovascular at 2 sites in Japan.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of the TurboHawk for the treatment of peripheral arterial disease (PAD) in the superficial femoral and/or the popliteal arteries with the Japanese population. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Atherectomy Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesJapan
- Study dates
- Jun 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provides written informed consent
- Willing to comply with follow-up evaluations at specified times
- Has a Rutherford Clinical Category Score of 2-4
- Disease located within the femoropopliteal artery
- Has evidence of ≥ 50% stenosis or occlusion in the superficial femoral and/or popliteal, confirmed by angiography
- Each discrete target lesion's length is ≥4cm and ≤ 15 cm
- Reference vessel diameter is ≥ 3.5 mm and ≤ 7.0 mm
Who cannot join
- Previously implanted stent(s) or stent graft(s) in target leg
- Life expectancy less than 12 months
- Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure
- Has in-stent restenosis of the target lesion
- Has an aneurysmal target vessel
- Has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Kasukabe Chuo General Hospital
Kasukabe, Saitama, 344-0063
Jikei University School of Medicine
Minato-ku, Tokyo, 105-8471
About this study
Official title: Determination of Safety and Effectiveness of the TurboHawk and the SpiderFX for the Treatment of Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries in Japan
The objective of this study is to evaluate the safety and effectiveness of the TurboHawk for the treatment of peripheral arterial disease (PAD) in the superficial femoral and/or the popliteal arteries with the Japanese population.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Atherectomy Catheter
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atherectomy CatheterDevice
Atherectomy Catheter, TurboHawk, is used for Angioplasty. Spider FX can concomitantly be used with TurboHawk.
TurboHawkTM LS-C, TurboHawk LX-C, TurboHawk SS-CL and TurboHawk SX-C are participated in this arm.
| Study group | Role | What they receive |
|---|---|---|
| TurboHawk | Experimental | This study is designed as a single arm study. For angioplasty, the Atherectomy Catheter, TurboHawk is used in this arm. Spider FX, the Distal Embolus Protection Device, can concomitantly be used with TurboHawk Receives: Device: Atherectomy Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency Rate
Measured: 180 Days
Secondary outcomes (8)
Technical procedural success
Measured: 30 Days
Preservation of the number of run-off vessels determined by angiography
Measured: intra operative
Event free survival
Measured: 30 Days , 180 Days and One Year
Amputation Rate
Measured: 30 Days , 180 Days and One Year
Improvement in Rutherford Clinical Category
Measured: 30 Days , 180 Days and One Year
Improvement in Ankle-Brachial Index
Measured: 30 Days , 180 Days and One Year
Clinically driven target lesion revascularisation
Measured: 30 Days , 180 Days and One Year
Clinically driven target vessel revascularisation
Measured: 30 Days , 180 Days and One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Takao Ohki, MD, Principal investigator, Jikei University School of MedicineHiroshi Ando, MD, Principal investigator, Kasukabe Chuo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169921
- Sponsor's protocol ID
- CVJ-12-02-01
- Status last verified
- Apr 2019
- First submitted
- 8 Jun 2014
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Safety and Effectiveness of the TurboHawk and the SpiderFX for the Treatment of Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries in Japan
- ClinicalTrials.gov ID
- NCT02169921
- Acronym / sponsor ID
- CVJ-12-02-01
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and effectiveness of the TurboHawk for the treatment of peripheral arterial disease (PAD) in the superficial femoral and/or the popliteal arteries with the Japanese population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TurboHawk | Experimental | Device: Atherectomy CatheterThis study is designed as a single arm study. For angioplasty, the Atherectomy Catheter, TurboHawk is used in this arm. Spider FX, the Distal Embolus Protection Device, can concomitantly be used with TurboHawk |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provides written informed consent
- Willing to comply with follow-up evaluations at specified times
- Has a Rutherford Clinical Category Score of 2-4
- Disease located within the femoropopliteal artery
- Has evidence of ≥ 50% stenosis or occlusion in the superficial femoral and/or popliteal, confirmed by angiography
Key exclusion criteria (6 listed)
- Previously implanted stent(s) or stent graft(s) in target leg
- Life expectancy less than 12 months
- Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure
- Has in-stent restenosis of the target lesion
- Has an aneurysmal target vessel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atherectomy CatheterAtherectomy Catheter, TurboHawk, is used for Angioplasty. Spider FX can concomitantly be used with TurboHawk. TurboHawkTM LS-C, TurboHawk LX-C, TurboHawk SS-CL and TurboHawk SX-C are participated in this arm. | Device | TurboHawk |
Primary outcome
Primary Patency Rate
Time frame: 180 Days
8 secondary outcomes
Technical procedural success
Time frame: 30 Days
Preservation of the number of run-off vessels determined by angiography
Time frame: intra operative
Event free survival
Time frame: 30 Days , 180 Days and One Year
Amputation Rate
Time frame: 30 Days , 180 Days and One Year
Improvement in Rutherford Clinical Category
Time frame: 30 Days , 180 Days and One Year
Improvement in Ankle-Brachial Index
Time frame: 30 Days , 180 Days and One Year
Clinically driven target lesion revascularisation
Time frame: 30 Days , 180 Days and One Year
Clinically driven target vessel revascularisation
Time frame: 30 Days , 180 Days and One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takao Ohki, MD principal investigator
Jikei University School of Medicine
Hiroshi Ando, MD principal investigator
Kasukabe Chuo General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atherectomy Catheter in people with Peripheral Arterial Disease, run by Medtronic Endovascular at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency Rate (time frame: 180 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.