Femoropopliteal Artery DiseaseNCT02701816
Korean Multicenter Registry of INNOVA Stent for Femoropopliteal Artery Disease: (K-INNOVA Registry)
An observational study of Femoropopliteal Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Prospective, single-arm, multi-center registry study A total of 150 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included. Patients will be followed clinically for 12 months after the procedure. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Femoropopliteal Artery Disease
- What is being tested?
- innova stent (Boston scientific)
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Jan 2021
- Phase
- Observational
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Femoropopliteal artery disease
Who may be able to join
- Age 19 years of older
- Symptomatic peripheral artery disease:
- Moderate or severe claudication (Rutherford category 2 or 3)
- Critical limb ischemia (Rutherford category 4-5)
- Femoropopliteal artery lesions with stenosis > 50%
- ABI < 0.9
- Patients with signed informed consent
Who cannot join
- Acute critical limb ischemia
- Severe critical limb ischemia (Rutherford category 6)
- Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
- In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment)
- Bypass graft lesions
- Age > 85 years
Show all 12Show fewer
- Severe hepatic dysfunction (> 3 times normal reference values)
- Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- LVEF < 40% or clinically overt congestive heart failure
- Pregnant women or women with potential childbearing
- Life expectancy <1 year due to comorbidity
- Untreated proximal inflow disease of the ipsilateral iliac arteries (more than 50% stenosis or occlusion)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, 120-752
Young-Guk Ko, MD, 82-2-2228-8460, ygko@yuhs.ac
Hyuck-Moon Kwon, MD, Ph.D, 82-2-2019-3310, kwonhm@yuhs.ac
About this study
- Prospective, single-arm, multi-center registry study
- A total of 150 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included.
- Patients will be followed clinically for 12 months after the procedure.
- Duplex ultrasound, CT or catheter-based angiography follow-up according to participating hospital's protocol will be performed at 12 months.
- Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12 months.
- Quality of life by standardized questionnaires (at baseline \& at 1 \& 12 months)
- Conditions
- Femoropopliteal Artery Disease
- Being tested
- innova stent (Boston scientific)
- Keywords
- Peripheral Artery Disease, Femoropopliteal Artery, Nitinol Stent, Restenosis
- 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.
innova stent (Boston scientific)Device
| Study group | Role | What they receive |
|---|---|---|
| K-INNOVA | Patients with femoropopliteal artery disease undergoing endovascular therapy using Innova stent (Boston Scientific). Receives: Device: innova stent (Boston scientific) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency rate
Absence of restenosis >50%
Measured: 12 months after the index procedure
Secondary outcomes (3)
Target lesion revascularization rate
Measured: 12 months
Stent fracture rate
Measured: 12 months
Quality of life
Quality of life by standardized questionnaires
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoropopliteal Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701816
- Sponsor's protocol ID
- 1-2015-0074
- Status last verified
- Sep 2020
- First submitted
- 29 Feb 2016
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Multicenter Registry of INNOVA Stent for Femoropopliteal Artery Disease: (K-INNOVA Registry)
- ClinicalTrials.gov ID
- NCT02701816
- Acronym / sponsor ID
- 1-2015-0074
- Conditions
- Femoropopliteal Artery Disease
- Keywords
- Peripheral Artery Disease, Femoropopliteal Artery, Nitinol Stent, Restenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 8 Mar 2016 (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.
- Prospective, single-arm, multi-center registry study
- A total of 150 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included.
- Patients will be followed clinically for 12 months after the procedure.
- Duplex ultrasound, CT or catheter-based angiography follow-up according to participating hospital's protocol will be performed at 12 months.
- Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12 months.
- Quality of life by standardized questionnaires (at baseline \& at 1 \& 12 months)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| K-INNOVA | – | Device: innova stent (Boston scientific)Patients with femoropopliteal artery disease undergoing endovascular therapy using Innova stent (Boston Scientific). |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Femoropopliteal artery disease
Key inclusion criteria (7 listed)
- Age 19 years of older
- Symptomatic peripheral artery disease:
- Femoropopliteal artery lesions with stenosis > 50%
- ABI < 0.9
- Patients with signed informed consent
Key exclusion criteria (12 listed)
- Acute critical limb ischemia
- Severe critical limb ischemia (Rutherford category 6)
- Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
- In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment)
- Bypass graft lesions
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 |
|---|---|---|
| innova stent (Boston scientific) | Device | K-INNOVA |
Primary outcome
Primary patency rate
Time frame: 12 months after the index procedure
Absence of restenosis >50%
3 secondary outcomes
Target lesion revascularization rate
Time frame: 12 months
Stent fracture rate
Time frame: 12 months
Quality of life
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Femoropopliteal Artery Disease
Active, not recruiting
SELUTION4SFA Trial
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoropopliteal Artery Disease, run by Yonsei University at 1 site in South Korea.
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 12 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: status not confirmed, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency rate (time frame: 12 months after the index procedure). 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 28 Sep 2020.