Femoral Artery StenosisDELTANCT05608655
DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis
A study testing DKutting LL balloon and Chocolate balloon in people with Femoral Artery Stenosis and Popliteal Artery Stenosis, run by DK Medical Technology (Suzhou) Co., Ltd. at 14 sites in China.
Trial summary
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Femoral Artery Stenosis, Popliteal Artery Stenosis
- What is being tested?
- DKutting LL balloon and Chocolate balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 14 sitesChina
- Study dates
- 27 Dec 2022to 4 Feb 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 year-old male \& non-pregnant female
- Patients with Arteriosclerosis Obliterans of Lower Extremities, including stenosis or osculation in femoropopliteal artery.
- Rutherford clinical category-Becker class: 2 to 5
- Patients understand the purpose of the study, will voluntarily participate in the study and sign informed consent. Patients are willing to undergo clinical follow-up as required by this study.
- Digital subtraction angiography (DSA) shows femoropopliteal artery stenosis above 70%, appropriate for treatment with balloon angioplasty
- Reference vessel diameter from 2.5 to 7mm; Total length of lesion is less than 200mm; Total length of osculation lesion is less than 100mm
- Only one target lesion needs to be Treated. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician. The number non-target lesions are limited to maximum 3.
Who cannot join
- Acute or sub-acute thrombosis exist in target lesion
- Severe calcified lesion (PACSS Grading 4)
- Guidewire cannot cross target lesion
- Amputation planned within 30 days
- In-stent restenosis
- Flow-limiting dissection (NHLBI grading: D-F) occurred in target lesion by pre-dilation
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- No other lumen-reduction devices (such as: cutting balloon, dual-wire balloon, Hawk, ELCA etc.) are treated before or after test/control group treatment.
- Before test/control group treatment, target lesion was expanded by Antegrade Dissection Re-entry (ADR) technique.
- Patient who cannot accept anticoagulant or antiplatelet therapy
- Aware of patient allergic to heparin, contrast, aspirin and clopidogrel, anesthetics
- Patients who have not completed clinical trials of other drugs or devices
- Patients with poor compliance and unable to complete the study, which is identified by investigator.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
China-Japan Friendship Hospital
Beijing
Xuanwu Hospital of Capital Medical University
Beijing
Xiangya Hospital of Central South University
Changsha, Hunan
Hospital of Chengdu Traditional Chinese Medicine University
Chengdu, Sichuan
The Third People's Hospital of Chengdu
Chengdu, Sichuan
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
The First Affiliated Hospital of Naval Medical University
Shanghai
Zhongshan Hospital of Fudan University
Shanghai
Suzhou Municipal Hospital
Suzhou, Jiangsu
Tianjin Medical University General Hospital
Tianjin
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis
Read the detailed description
This is a prospective, multi-center, randomized controlled, open-label, noninferior study to evaluate achievement of optimal PTA dilatation. A total of 188 patients will be enrolled from 14 sites in China. All patients enrolled will be assigned to the test group (DKutting LL balloon, n=94) and the control group (Chocolate balloon, n=94) with randomized allocation ratio of 1:1.
Primary endpoint is percentage of PTA cases in which <30% diameter stenosis without a flow limiting dissection is achieved. A 30-day after procedure follow-up will be conducted for all 188 patients.
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis
- Being tested
- DKutting LL balloon, Chocolate balloon
- Keywords
- PTA Scoring Balloon, Optimal Balloon Angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKutting LL balloonDevice
After pre-dilation balloon is used (if any), DKutting LL balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment
Chocolate balloonDevice
After pre-dilation balloon is used (if any), Chocolate balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment
| Study group | Role | What they receive |
|---|---|---|
| DKutting | Experimental | DKutting LL Scoring Balloon, DK Medtech Co Ltd Receives: Device: DKutting LL balloon |
| Chocolate | Active comparator | Chocolate Balloon, TriReme Medical LLC Receives: Device: Chocolate balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of Optimal PTA in Percent
Percentage of PTA cases in which <30% diameter stenosis without a flow limiting dissection (NHLBI grading: D-F). Residual stenosis in percent and dissection NHLBI grading are accessed by independent core-lab with Medis Suite XA based on in-procedure QCA angiography. [0-100%, higher the better]
Measured: 1 day
Secondary outcomes (7)
Device Success Rate in Percent
Device Success defined as successful delivery to the target lesion, deployment without balloon rupture, and retrieval after procedure, as qualitatively accessed by physician. [0-100%, higher the better]
Measured: 1 day
Numerical Acute Lumen Gain in mm
In-lesion acute lumen gain defined as minimal lumen diameter (MLD) in lumen after dilatation by either arm device minus baseline MLD, as accessed by independent core-lab with Medis Suite XA based on in-procedure QCA angiography. [0-3mm, higher the better]
Measured: 1 day
Technical Success Rate in percent
Percentage of target Lesion achieved <30% diameter stenosis without a flow limiting dissection (NHLBI grading: D-F) and No Adverse Event happened in hospital. [0-100%, higher the better]
Measured: 0-7 days
Freedom from clinical-driven TLR rate in percent
Freedom from clinical-driven target lesion revascularization 1 month post procedure [0-100%, higher the better]
Measured: 30+/-7 Days post procedure
Rutherford Grading Reduction in percent
Percentage of both groups' patent number, whose Rutherford Grading [0-6, lower is reduced by at least 1 grade post procedure, compared with pre-procedure grade. [0-100%, higher the better]
Measured: 30+/-7 Days post procedure
Freedom from Amputation above ankle rate in percent
Percentage of both groups' patient number who is free from Amputation above ankle 1 month post procedure. [0-100%, higher the better]
Measured: 30+/-7 Days post procedure
Numerical Ankle Brachial Index
Record of both groups' patient's Ankle Brachial Index (ABI) pre/post procedure by Doppler ultrasonic stethoscope. [ABI≤0.9: confirmed peripheral artery disease; ABI≥0.97: normal people]
Measured: 0-7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start27 Dec 2022
- Primary completion10 Jan 2024
- Study completion4 Feb 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weiguo Fu, Dr., Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608655
- Sponsor's protocol ID
- VP-P-22-005
- Acronym
- DELTA
- Status last verified
- Feb 2024
- First submitted
- 21 Oct 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis
- ClinicalTrials.gov ID
- NCT05608655
- Acronym / sponsor ID
- DELTA / VP-P-22-005
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis
- Keywords
- PTA Scoring Balloon, Optimal Balloon Angioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- DK Medical Technology (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 4 Feb 2024 (actual)
- First posted
- 8 Nov 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.
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis
Detailed description
This is a prospective, multi-center, randomized controlled, open-label, noninferior study to evaluate achievement of optimal PTA dilatation. A total of 188 patients will be enrolled from 14 sites in China. All patients enrolled will be assigned to the test group (DKutting LL balloon, n=94) and the control group (Chocolate balloon, n=94) with randomized allocation ratio of 1:1.
Primary endpoint is percentage of PTA cases in which <30% diameter stenosis without a flow limiting dissection is achieved. A 30-day after procedure follow-up will be conducted for all 188 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DKutting | Experimental | Device: DKutting LL balloonDKutting LL Scoring Balloon, DK Medtech Co Ltd |
| Chocolate | Active comparator | Device: Chocolate balloonChocolate Balloon, TriReme Medical LLC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-80 year-old male \& non-pregnant female
- Patients with Arteriosclerosis Obliterans of Lower Extremities, including stenosis or osculation in femoropopliteal artery.
- Rutherford clinical category-Becker class: 2 to 5
- Patients understand the purpose of the study, will voluntarily participate in the study and sign informed consent. Patients are willing to undergo clinical follow-up as required by this study.
- Digital subtraction angiography (DSA) shows femoropopliteal artery stenosis above 70%, appropriate for treatment with balloon angioplasty
Key exclusion criteria (12 listed)
- Acute or sub-acute thrombosis exist in target lesion
- Severe calcified lesion (PACSS Grading 4)
- Guidewire cannot cross target lesion
- Amputation planned within 30 days
- In-stent restenosis
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 balloonAfter pre-dilation balloon is used (if any), DKutting LL balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment | Device | DKutting |
| Chocolate balloonAfter pre-dilation balloon is used (if any), Chocolate balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment | Device | Chocolate |
Primary outcome
Achievement of Optimal PTA in Percent
Time frame: 1 day
Percentage of PTA cases in which <30% diameter stenosis without a flow limiting dissection (NHLBI grading: D-F). Residual stenosis in percent and dissection NHLBI grading are accessed by independent core-lab with Medis Suite XA based on in-procedure QCA angiography. [0-100%, higher the better]
7 secondary outcomes
Device Success Rate in Percent
Time frame: 1 day
Numerical Acute Lumen Gain in mm
Time frame: 1 day
Technical Success Rate in percent
Time frame: 0-7 days
Freedom from clinical-driven TLR rate in percent
Time frame: 30+/-7 Days post procedure
Rutherford Grading Reduction in percent
Time frame: 30+/-7 Days post procedure
Freedom from Amputation above ankle rate in percent
Time frame: 30+/-7 Days post procedure
Numerical Ankle Brachial Index
Time frame: 0-7days
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 20 Feb 2024.
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A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
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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.
Weiguo Fu, Dr. principal investigator
Shanghai Zhongshan Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DKutting LL balloon and Chocolate balloon in people with Femoral Artery Stenosis and Popliteal Artery Stenosis, run by DK Medical Technology (Suzhou) Co., Ltd. at 14 sites 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 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: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
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?
Achievement of Optimal PTA in Percent (time frame: 1 day). 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 20 Feb 2024.