Femoral Artery StenosisDkuLL CALVEPNCT07397390
an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified Lesions
An observational study of Femoral Artery Stenosis and Angioplasty, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial summary
This is a prospective, single-center, single-arm, observational study. It plans to enroll 58 patients with moderate to severely calcified lesions in the femoropopliteal or infrapopliteal arteries. Participants will be treated with the Scoring Balloon Dilatation Catheter manufactured by DK Medtech (Suzhou) Co., Ltd. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Femoral Artery Stenosis, Angioplasty, Cutting Balloon Angioplasty
- What is being tested?
- DKutting LL scoring balloon angioplasty
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2026to 30 Mar 2027
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: lower limb ischemia caused by calcified lesion in femoral-popliteal and infra-popliteal artery
Who may be able to join
- Age ≥ 18 years and ≤ 85 years.
- Clinical diagnosis of lower extremity atherosclerotic arterial disease, with a Rutherford Classification of Category 2-5.
- The patient has provided written informed consent.
- Life expectancy > 1 year.
- Confirmed by clinical and CTA examination: de novo or restenotic lesions after PTA in the femoropopliteal or infrapopliteal arteries, with no stent implantation within 2 cm of the target lesion. Stenosis ≥70% or chronic total occlusion (CTO).
- Lesion confirmed by CTA and color Doppler to have moderate to severe calcification (PACSS Grade 3-4). Lesion can be single or tandem, with a total length ≤150 mm. Reference vessel diameter near the target lesion ≥2 mm.
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- Allowable location of the target lesion: ≥1 cm distal to the common femoral artery bifurcation, and up to 10 cm above the ankle.
- If the lesion is below-the-knee (BTK), the inflow vessels must have no non-target lesions, or any non-target lesions must be successfully treated with the current device without vascular complications.
- No serious vascular complications such as flow-limiting dissection occur after pre-dilation of the target lesion.
- Presence of at least one reconstructible infrapopliteal runoff vessel patent to the ankle.
Who cannot join
- Allergy to contrast media.
- Coagulopathy; severe hepatic insufficiency (ALT or AST > 3 times the upper limit of normal).
- Cardiac insufficiency (New York Heart Association Class III-IV).
- Life expectancy < 1 year.
- Acute cardiovascular events (e.g., acute myocardial infarction, stroke) within the past 3 months; active gastrointestinal bleeding affecting the use of anticoagulant/antiplatelet therapy.
- Previous stent implantation or bypass surgery in the target vessel.
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- Acute/subacute limb ischemia or thrombotic lesions.
- Contraindications to anticoagulation or antiplatelet therapy.
- Failure to cross the lesion with a guidewire during the procedure; anticipation that the IVUS catheter or DKutting balloon will be unable to cross the lesion after pre-dilation.
- Intraoperative occurrence of severe complications requiring conversion to other treatment methods (e.g., bypass surgery).
- Pregnant or lactating women.
- Active infection at the intended treatment site; foot wounds reaching WIfI Stage 3, or ankle/foot ulcers primarily of non-ischemic etiology.
- Patient withdrawal of informed consent.
- Planned amputation.
- Planned use of adjunctive therapy devices (e.g., atherectomy, laser).
- Participation in another interventional drug/device clinical study for lower limb arteries where the primary endpoint has not been reached, or planned participation in such a study.
- Patient is bedridden or unable to walk.
- Presence of an aneurysm in the ipsilateral limb vasculature.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
About this study
Official title: A Prospective, Single-Arm Observational Study on the Effectiveness and Safety of the DKutting® LL Balloon in VEssel Preparation for CALcified Lesions in Infra-inguinal Arteries, the DkuLL CALVEP Study.
This is a prospective, single-center, single-arm, observational study. It plans to enroll 58 patients with moderate to severely calcified lesions in the femoropopliteal or infrapopliteal arteries. Participants will be treated with the Scoring Balloon Dilatation Catheter manufactured by DK Medtech (Suzhou) Co., Ltd. The study aims to evaluate the immediate technical success rate and the improvement in lumen area and calcification burden as assessed by IVUS following percutaneous transluminal angioplasty with the scoring balloon. Clinical follow-ups will be conducted at discharge (or within 7 days), 1 month, 3 months, and 6 months post-procedure to observe secondary endpoints including the incidence of clinically driven target lesion revascularization and changes in Rutherford classification
- Conditions
- Femoral Artery Stenosis, Angioplasty, Cutting Balloon Angioplasty, Calcifications, Vascular, Intravascular Imaging Device, Peripheral Artery Disease
- Being tested
- DKutting LL scoring balloon angioplasty
- Keywords
- Peripheral Arterial Disease, Femoropopliteal Artery, Infrapopliteal Artery, Calcified Lesions, Scoring Balloon, Angioplasty, Vessel Preparation, Intravascular Ultrasound (IVUS), Observational Study
- Medical subject headings
- Vascular Calcification, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKutting LL scoring balloon angioplastyDevice
Following the detection of calcified lesions by Intravascular Ultrasound (IVUS), and aided by its accurate measurements of lesion diameter and length, percutaneous transluminal angioplasty (PTA) was performed using the DKutting LL scoring balloon
| Study group | Role | What they receive |
|---|---|---|
| Dkutting LL treatment group | IVUS facilitated DKutting LL angioplasty Receives: Device: DKutting LL scoring balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary effectiveness outcome
Technical Success Rate:
Definition: Immediate post-procedural residual stenosis ≤30% after dilation with the Scoring Balloon Dilatation Catheter or a conventional balloon catheter, and without the occurrence of severe flow-limiting dissection (Grade D-F according to the National Heart, Lung, and Blood Institute (NHLBI) classification).
Measured: immediately after the intervention
primary safety outcome
Incidence of emergency target lesion revascularization, unplanned amputation above the ankle on the target side, or grade D or higher flow-limiting dissection or perforation requiring intervention
Measured: 1 month
Secondary outcomes (7)
Primary Patency Rate at 30 days
Freedom from clinically driven target lesion revascularization (CD-TLR) and a peak systolic velocity ratio (PSVR) of <2.4 on duplex ultrasound.
Measured: 1 month
Primary Patency Rate at 6 months
Freedom from clinically driven target lesion revascularization (CD-TLR) and a peak systolic velocity ratio (PSVR) of <2.4 on duplex ultrasound.
Measured: 6 months
Incidence of Clinically Driven Target Lesion Revascularization (CD-TLR) at 6 months
The need for repeat revascularization in patients with clinical symptoms, including recurrent rest pain, worsening ulcer, or new foot ulcer. Revascularization methods include endarterectomy, bypass surgery, or repeat endovascular angioplasty.
Measured: 6 months
Change in Rutherford Classification at 1 month post-procedure
The proportion of patients showing an improvement of at least one category in the Rutherford Classification.
Measured: 1 month
Intraoperative Complication Rate Related to Percutaneous Transluminal Angioplasty (PTA)
Includes the occurrence of immediate flow-limiting dissection (NHLBI Grade A-F) after dilation with the Scoring Balloon Catheter, vessel perforation caused by PTA, and distal embolism caused by PTA
Measured: immediately after the intervention
ΔMLA (Change in Minimum Lumen Area)
Assessed by Intravascular Ultrasound (IVUS) to preliminarily evaluate the effectiveness of the DKutting balloon in vessel preparation for lower limb arterial calcified lesions, with the primary metric being the immediate post-procedural increase in MLA. Calculated as the difference in MLA measured by IVUS before and immediately after PTA.
Measured: immediately after the intervention
ΔCalcification Burden Improvement
Assessed by IVUS, measured as the change in the arc of continuous calcification in the vessel wall cross-section. Calculated as the difference in the arc of continuous calcification (differentiating between intimal and medial) measured by IVUS before and immediately after PTA.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start17 Mar 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Artery StenosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Donghua, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397390
- Sponsor's protocol ID
- PJ-KS-KY-2025-940(X)
- Other IDs
- 20251012
- Acronym
- DkuLL CALVEP
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm Observational Study on the Effectiveness and Safety of the DKutting® LL Balloon in VEssel Preparation for CALcified Lesions in Infra-inguinal Arteries, the DkuLL CALVEP Study.
- ClinicalTrials.gov ID
- NCT07397390
- Acronym / sponsor ID
- DkuLL CALVEP / PJ-KS-KY-2025-940(X)
- Conditions
- Femoral Artery Stenosis, Angioplasty, Cutting Balloon Angioplasty, Calcifications, Vascular, Intravascular Imaging Device, Peripheral Artery Disease
- Keywords
- Peripheral Arterial Disease, Femoropopliteal Artery, Infrapopliteal Artery, Calcified Lesions, Scoring Balloon, Angioplasty, Vessel Preparation, Intravascular Ultrasound (IVUS)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 9 Feb 2026 (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.
This is a prospective, single-center, single-arm, observational study. It plans to enroll 58 patients with moderate to severely calcified lesions in the femoropopliteal or infrapopliteal arteries. Participants will be treated with the Scoring Balloon Dilatation Catheter manufactured by DK Medtech (Suzhou) Co., Ltd. The study aims to evaluate the immediate technical success rate and the improvement in lumen area and calcification burden as assessed by IVUS following percutaneous transluminal angioplasty with the scoring balloon. Clinical follow-ups will be conducted at discharge (or within 7 days), 1 month, 3 months, and 6 months post-procedure to observe secondary endpoints including the incidence of clinically driven target lesion revascularization and changes in Rutherford classification
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dkutting LL treatment group | – | Device: DKutting LL scoring balloon angioplastyIVUS facilitated DKutting LL angioplasty |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- lower limb ischemia caused by calcified lesion in femoral-popliteal and infra-popliteal artery
Key inclusion criteria (10 listed)
- Age ≥ 18 years and ≤ 85 years.
- Clinical diagnosis of lower extremity atherosclerotic arterial disease, with a Rutherford Classification of Category 2-5.
- The patient has provided written informed consent.
- Life expectancy > 1 year.
- Confirmed by clinical and CTA examination: de novo or restenotic lesions after PTA in the femoropopliteal or infrapopliteal arteries, with no stent implantation within 2 cm of the target lesion. Stenosis ≥70% or chronic total occlusion (CTO).
Key exclusion criteria (18 listed)
- Allergy to contrast media.
- Coagulopathy; severe hepatic insufficiency (ALT or AST > 3 times the upper limit of normal).
- Cardiac insufficiency (New York Heart Association Class III-IV).
- Life expectancy < 1 year.
- Acute cardiovascular events (e.g., acute myocardial infarction, stroke) within the past 3 months; active gastrointestinal bleeding affecting the use of anticoagulant/antiplatelet therapy.
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 |
|---|---|---|
| DKutting LL scoring balloon angioplastyFollowing the detection of calcified lesions by Intravascular Ultrasound (IVUS), and aided by its accurate measurements of lesion diameter and length, percutaneous transluminal angioplasty (PTA) was performed using the DKutting LL scoring balloon | Device | Dkutting LL treatment group |
Primary outcome
primary effectiveness outcome
Time frame: immediately after the intervention
Technical Success Rate: Definition: Immediate post-procedural residual stenosis ≤30% after dilation with the Scoring Balloon Dilatation Catheter or a conventional balloon catheter, and without the occurrence of severe flow-limiting dissection (Grade D-F according to the National Heart, Lung, and Blood Institute (NHLBI) classification).
primary safety outcome
Time frame: 1 month
Incidence of emergency target lesion revascularization, unplanned amputation above the ankle on the target side, or grade D or higher flow-limiting dissection or perforation requiring intervention
7 secondary outcomes
Primary Patency Rate at 30 days
Time frame: 1 month
Primary Patency Rate at 6 months
Time frame: 6 months
Incidence of Clinically Driven Target Lesion Revascularization (CD-TLR) at 6 months
Time frame: 6 months
Change in Rutherford Classification at 1 month post-procedure
Time frame: 1 month
Intraoperative Complication Rate Related to Percutaneous Transluminal Angioplasty (PTA)
Time frame: immediately after the intervention
ΔMLA (Change in Minimum Lumen Area)
Time frame: immediately after the intervention
ΔCalcification Burden Improvement
Time frame: immediately after the intervention
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 3 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Femoral Artery Stenosis and Angioplasty, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
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 10 inclusion and 18 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: enrolling by invitation, as of the sponsor's last update on 3 Apr 2026. 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 China. 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?
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 effectiveness outcome (time frame: immediately after the intervention). The study lists 2 primary outcomes in all. 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 3 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.