Femoropopliteal Artery DiseaseARTEMISNCT05307263
Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease
A study testing Combination therapy of atherectomy and DCB and DCB alone in people with Femoropopliteal Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Prospective, multi-center, randomized, controlled comparison study A total of 300 subjects with complex femoropopliteal artery disease will be included according to inclusion and exclusion criteria. Complex lesions include long lesions (>150 mm), calcified lesions (PACSS grade 2-4) and in-stent lesions. 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?
- Combination therapy of atherectomy and DCB and DCB alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Sep 2022to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age 19 years or older
- Symptomatic peripheral artery disease:
- Moderate or severe claudication (Rutherford category 2 or 3)
- Critical limb ischemia (Rutherford category 4 or 5)
- Femoropopliteal artery disease (stenosis > 50%) with one of following complex lesion characteristics: - long lesion (>150 mm), in-stent restenosis, calcified lesion (PACCS grade 2-4)
- Femoropopliteal artery lesions that operators consider appropriate for treatment with both atherectomy plus drug-coated balloons and drug-coated balloons alone
- Patients with signed informed consent
Who cannot join
- Acute critical limb ischemia
- Severe critical limb ischemia (Rutherford category 6)
- Contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agents due to severe hypersensitive reactions
- Age > 85 years
- Severe hepatic dysfunction (> 3 times normal reference values)
- Significant thrombocytopenia, anemia, or known bleeding diathesis
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- LVEF < 35% or clinically overt congestive heart failure
- Pregnant women or women with potential childbearing
- Life expectancy <1 year due to comorbidity
- Previous bypass surgery in the target femoropopliteal artery
- Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Young-Guk Ko, MD, PhD, 82-2-2228-8460, ygko@yuhs.ac
About this study
Official title: Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease (ARTEMIS Trial)
- Prospective, multi-center, randomized, controlled comparison study
- A total of 300 subjects with complex femoropopliteal artery disease will be included according to inclusion and exclusion criteria. Complex lesions include long lesions (>150 mm), calcified lesions (PACSS grade 2-4) and in-stent lesions.
- Patients will be randomized in a 1:1 manner into atherectomy plus drug-coated balloon (DCB) or angiography-guided intervention group. • The randomization will be startified by the participating center and in-stent restenosis lesion. • For the DCB treatment, either IN.PACT (Medtronic) or Ranger (Boston Scientific) DCB will be used. • For the atherectomy, HawkOne (Medtronic), Jetstream (Boston scientific), or Rotarex (Straub Medical) will be used. • The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. • Ankle-brachial index and Image study follow-up (Duplex US, CT angiography, or catheter angiography) will be performed at 1 year.
- Patients will be followed clinically for 2 years after the procedure.
- Conditions
- Femoropopliteal Artery Disease
- Being tested
- Combination therapy of atherectomy and DCB, DCB alone
- Keywords
- Femoropopliteal artery disease, drug-coated balloon, angioplasty, atherectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination therapy of atherectomy and DCBProcedure or surgery
The target lesion in femoropopliteal artery will be treated with atherectomy folloewd by DCB. The choice of atherectomy devices (HawkOne, Jectstream, or Rotarex)and DCBs (IN.PACT or Ranger) will be left to the operator's decision. In presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of bare nitinol stents is recommended. Implantational of drug-eluting stents is not allowed.
DCB aloneProcedure or surgery
The target lesion in femoropopliteal artery will be treated with DCB. The choice of DCBs (IN.PACT or Ranger) will be left to the operator's decision. In presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of bare nitinol stents is recommended. Implantational of drug-eluting stents is not allowed.
| Study group | Role | What they receive |
|---|---|---|
| Atherectomy plus DCB | Active comparator | Not described Receives: Procedure: Combination therapy of atherectomy and DCB |
| DCB | Active comparator | Not described Receives: Procedure: DCB alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency
Primary patency is defined as absence of restenosis >50% by Duplex ultrasound, CT angiography, or catheter-based angiography
Measured: 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start15 Sep 2022
- Primary completion30 Jun 2029 (estimated)
- Study completionDec 2029 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 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
- NCT05307263
- Sponsor's protocol ID
- 4-2022-0051
- Acronym
- ARTEMIS
- Status last verified
- May 2025
- First submitted
- 23 Mar 2022
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease (ARTEMIS Trial)
- ClinicalTrials.gov ID
- NCT05307263
- Acronym / sponsor ID
- ARTEMIS / 4-2022-0051
- Conditions
- Femoropopliteal Artery Disease
- Keywords
- Femoropopliteal artery disease, drug-coated balloon, angioplasty, atherectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 1 Apr 2022 (actual)
- 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, multi-center, randomized, controlled comparison study
- A total of 300 subjects with complex femoropopliteal artery disease will be included according to inclusion and exclusion criteria. Complex lesions include long lesions (>150 mm), calcified lesions (PACSS grade 2-4) and in-stent lesions.
- Patients will be randomized in a 1:1 manner into atherectomy plus drug-coated balloon (DCB) or angiography-guided intervention group. • The randomization will be startified by the participating center and in-stent restenosis lesion. • For the DCB treatment, either IN.PACT (Medtronic) or Ranger (Boston Scientific) DCB will be used. • For the atherectomy, HawkOne (Medtronic), Jetstream (Boston scientific), or Rotarex (Straub Medical) will be used. • The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. • Ankle-brachial index and Image study follow-up (Duplex US, CT angiography, or catheter angiography) will be performed at 1 year.
- Patients will be followed clinically for 2 years after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atherectomy plus DCB | Active comparator | Procedure: Combination therapy of atherectomy and DCB |
| DCB | Active comparator | Procedure: DCB alone |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 19 years or older
- Symptomatic peripheral artery disease:
- Femoropopliteal artery disease (stenosis > 50%) with one of following complex lesion characteristics: - long lesion (>150 mm), in-stent restenosis, calcified lesion (PACCS grade 2-4)
- Femoropopliteal artery lesions that operators consider appropriate for treatment with both atherectomy plus drug-coated balloons and drug-coated balloons alone
- Patients with signed informed consent
Key exclusion criteria (11 listed)
- Acute critical limb ischemia
- Severe critical limb ischemia (Rutherford category 6)
- Contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agents due to severe hypersensitive reactions
- Age > 85 years
- Severe hepatic dysfunction (> 3 times normal reference values)
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 |
|---|---|---|
| Combination therapy of atherectomy and DCBThe target lesion in femoropopliteal artery will be treated with atherectomy folloewd by DCB. The choice of atherectomy devices (HawkOne, Jectstream, or Rotarex)and DCBs (IN.PACT or Ranger) will be left to the operator's decision. In presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of bare nitinol stents is recommended. Implantational of drug-eluting stents is not allowed. | Procedure or surgery | Atherectomy plus DCB |
| DCB aloneThe target lesion in femoropopliteal artery will be treated with DCB. The choice of DCBs (IN.PACT or Ranger) will be left to the operator's decision. In presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of bare nitinol stents is recommended. Implantational of drug-eluting stents is not allowed. | Procedure or surgery | DCB |
Primary outcome
Primary patency
Time frame: 12 months post treatment
Primary patency is defined as absence of restenosis >50% by Duplex ultrasound, CT angiography, or catheter-based angiography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination therapy of atherectomy and DCB and DCB alone in people with 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 11 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: looking for participants now, as of the sponsor's last update on 4 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Young-Guk Ko, MD, PhD (82-2-2228-8460, ygko@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency (time frame: 12 months post treatment). 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 4 May 2025.