Peripheral Artery DiseaseNCT04885985
ACOART BTK RENEW：A Post Market Clinical Study
A study testing DEB catheter in people with Peripheral Artery Disease, run by Acotec Scientific Co., Ltd at 1 site in China.
Trial summary
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos\&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee artery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- DEB catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2021to 1 Apr 2027
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥18 years old and ≤75 years old
- 2. Rutherford clinical category classification：3,4 or 5
- 3. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in below-the-knee arteries which distal bloodflow is patent.
- 4. Reference vessel diameter is between 2 mm and 4 mm
- 5. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.
Who cannot join
- 1. Plasma creatinine clearance rate <30 mL/min
- 2. Acute vessel occlusion or acute thrombosis in target lesion
- 3. Planned amputation on the target limb
- 4. Subjects confined to bed that are completely non-ambulatory.
- 5. Thrombolytic therapy or surgical procedure on the target limb within 6 weeks prior to enrollment.
- 6. Life expectancy < 5 year.
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- 7. Cumulative length of 100% occluded target lesion(s)>150 mm
- 8. In-stent restenosis within the target lesion, or the distance between the target lesions and the stent was less than 20 mm
- 9. History of stroke within 90 days prior to enrollment
- 10. Known allergy to contrast agents, antiplatelet, anticoagulant, or thrombolytic therapy
- 11. Uncorrectable bleeding diathesis
- 12. The lesion of the inflow pathway cannot be identified due to the complete occlusion of the P3 segment of the popliteal artery
- 13. Pregnant or breastfeeding female subjects
- 14. Ability to cross a guidewire through target lesion
- 15. Patients who have participated in clinical trials of other medical devices or drugs during the same period
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, 1 recruiting
- Recruiting
Chui Yang Liu Hospital affiliated to Tsinghua University
Beijing, Beijing Municipality, 100021
Yang Yongjiu, 010-67700622, docyyj@126.com
About this study
Official title: A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon in the Treatment of the Below-the-knee Artery
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos\&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee artery.
- Conditions
- Peripheral Artery Disease
- Being tested
- DEB 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.
DEB catheterDevice
Trade name of DEB catheter: AcoArt Tulip (0.018") or AcoArt Litos (0.014")
| Study group | Role | What they receive |
|---|---|---|
| DEB catheter | Experimental | Use DEB catheter to treat the stenosis or occlusion in below popliteal artery of experimental arm Receives: Device: DEB catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency
Primary patency rate is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation.
Measured: 6 month
Secondary outcomes (8)
Major adverse event (MAE) rate
Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR
Measured: 30 days
Patency rate
Defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation.
Measured: 12 months,24 months,36 months,48 months ,60 months
Rate of major target limb amputation
A major adverse limb event is defined as above-ankle amputation of the treated limb
Measured: 12 months,24 months,36 months,48 months ,60 months
Rate of All-cause mortality
All-cause mortality at 12, 24, 36, 48, 60 months post procedure
Measured: 12 months,24 months,36 months,48 months ,60 months
Rate of clinically-driven target vessel revascularization (CD-TVR)
Clinically-driven target vessel revascularization (CD-TVR) at 12, 24, 36, 48, 60 months post procedure
Measured: 12 months,24 months,36 months,48 months ,60 months
Rate of clinically-driven target lesion revascularization (CD-TLR)
Clinically-driven target lesion revascularization (CD-TLR) at 12, 24, 36, 48, 60 months post procedure
Measured: 12 months,24 months,36 months,48 months ,60 months
Rate of ulcer healing
Ulcer healed or not; if not, improving, stagnant,worsening
Measured: 12 months,24 months,36 months,48 months ,60 months
Rate of distal embolization
Rate of distal embolization defined as occurrence significant distal embolization in target limb through the end of the procedure
Measured: through procedure completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start31 Dec 2021
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery 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
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acotec Scientific Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhuang Baixi, Principal investigator, Xiyuan Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885985
- Sponsor's protocol ID
- ACOART BTK RENEW
- Status last verified
- Jul 2024
- First submitted
- 10 May 2021
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon in the Treatment of the Below-the-knee Artery
- ClinicalTrials.gov ID
- NCT04885985
- Acronym / sponsor ID
- ACOART BTK RENEW
- Conditions
- Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Acotec Scientific Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 13 May 2021 (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.
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos\&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DEB catheter | Experimental | Device: DEB catheterUse DEB catheter to treat the stenosis or occlusion in below popliteal artery of experimental arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Age ≥18 years old and ≤75 years old
- 2. Rutherford clinical category classification：3,4 or 5
- 3. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in below-the-knee arteries which distal bloodflow is patent.
- 4. Reference vessel diameter is between 2 mm and 4 mm
- 5. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.
Key exclusion criteria (15 listed)
- 1. Plasma creatinine clearance rate <30 mL/min
- 2. Acute vessel occlusion or acute thrombosis in target lesion
- 3. Planned amputation on the target limb
- 4. Subjects confined to bed that are completely non-ambulatory.
- 5. Thrombolytic therapy or surgical procedure on the target limb within 6 weeks prior to enrollment.
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 |
|---|---|---|
| DEB catheterTrade name of DEB catheter: AcoArt Tulip (0.018") or AcoArt Litos (0.014") | Device | DEB catheter |
Primary outcome
Primary Patency
Time frame: 6 month
Primary patency rate is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation.
8 secondary outcomes
Major adverse event (MAE) rate
Time frame: 30 days
Patency rate
Time frame: 12 months,24 months,36 months,48 months ,60 months
Rate of major target limb amputation
Time frame: 12 months,24 months,36 months,48 months ,60 months
Rate of All-cause mortality
Time frame: 12 months,24 months,36 months,48 months ,60 months
Rate of clinically-driven target vessel revascularization (CD-TVR)
Time frame: 12 months,24 months,36 months,48 months ,60 months
Rate of clinically-driven target lesion revascularization (CD-TLR)
Time frame: 12 months,24 months,36 months,48 months ,60 months
Rate of ulcer healing
Time frame: 12 months,24 months,36 months,48 months ,60 months
Rate of distal embolization
Time frame: through procedure completion
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 1 Aug 2024.
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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.
Zhuang Baixi principal investigator
Xiyuan Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEB catheter in people with Peripheral Artery Disease, run by Acotec Scientific Co., Ltd 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 5 inclusion and 15 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 1 Aug 2024. 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?
Contact Zhuang Baixi (010-62835122, zhuangbaixi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency (time frame: 6 month). 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 1 Aug 2024.