Popliteal StenosisNCT03739580
DCB Compared Stenting in Popliteal Lesions
A study testing DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.) and Stent (Maris,Medtronic.USA or Sinus/Supera, Germany) in people with Popliteal Stenosis and Popliteal Artery Occlusion, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This is a randomized prospective study aiming to compare drug-coated balloons and stent deployment in Popliteal atherosclerotic occlusive lesions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Popliteal Stenosis, Popliteal Artery Occlusion, Diabetes
- What is being tested?
- DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.) and Stent (Maris,Medtronic.USA or Sinus/Supera, Germany)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2016to 1 Sep 2019
- 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
- Age 18 years or older
- Symptomatic peripheral artery disease:
- Moderate or severe claudication (Rutherford category 2 or 3)
- Critical limb ischemia (Rutherford category 4 or 5)
- Atherosclerotic popliteal artery disease (stenosis > 50%)
- Patients with signed informed consent
Who cannot join
- Acute critical limb ischemia
- Severe critical limb ischemia (Rutherford category 6)
- Involvement of SFA disease with stenosis
- Continous total occlusion of all proximal infrapopliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk).
- Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agent
- Age > 80 years
Show all 13Show 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
- Previous bypass surgery or stenting for the target popliteal 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.
China1 site, 1 recruiting
- Recruiting
Gu Yong Quan
Beijing, Beijing Municipality, 100053
Jian ming Guo, M.D., 13146369562, guojianming@aliyun.com
Yong quan Gu, M.D., 15901598209, gu15901598209@aliyun.com
About this study
Official title: The Comparison of Drug-coated Balloon With Stent Deployment in Popliteal Atherosclerotic Occlusive Lesions
This is a randomized prospective study aiming to compare drug-coated balloons and stent deployment in Popliteal atherosclerotic occlusive lesions.
- Conditions
- Popliteal Stenosis, Popliteal Artery Occlusion, Diabetes
- Being tested
- DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.), Stent (Maris,Medtronic.USA or Sinus/Supera, Germany)
- Keywords
- drug-coating balloon, stent, popliteal artery, atherosclerotic occlusion
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.)Device
for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment.
Stent (Maris,Medtronic.USA or Sinus/Supera, Germany)Device
for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment.
| Study group | Role | What they receive |
|---|---|---|
| drug-coating balloon | Experimental | drug-coating balloon (Orchid) intervention Receives: Device: DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.) |
| stent deployment | Active comparator | metal bare stent intervention Receives: Device: Stent (Maris,Medtronic.USA or Sinus/Supera, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency of claudicant patients
Claudicant patients (Rutherford C1-3), primary patency defined as PSVR（peak systolic velocity ratio) ≤2.4, absence of restenosis >50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months
Measured: 12 months after the index procedure
Salvage limb rate (for CLI patients)
Limb Salvage is defined as the freedom from secondary major amputation
Measured: 12 months after the index procedure
Secondary outcomes (7)
Rutherford classification
Measured: 12 months
ABI
Ankle Brachial index
Measured: 12 months
TcpO2
transcutaneous oxygen pressure
Measured: 12 months
Wagnar classification
incision healing information of Rutherford C5-6 patients
Measured: 12 months
Target vessel revascularization rate
frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel
Measured: 12 months
Index Limb Ischemia at 12-month Follow up
Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.
Measured: 12 months
Major Adverse Events at 12-month Post Procedure
Major adverse events included death, index limb ischemia, index limb amputation, clinically driven target lesion revascularization, and significant embolic events, which were defined as causing end-organ damage.
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 posted14 Nov 2018
- Study start1 Oct 2016
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Popliteal 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong-Quan Gu, Xuanwu Hospital, Beijing
- Investigators
- Yongquan Gu, M.D., Principal investigator, Xuanwu hospital CMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739580
- Sponsor's protocol ID
- DBSP-XWHCMU
- Status last verified
- Nov 2018
- First submitted
- 6 Nov 2018
- Last updated
- 14 Nov 2018
- Results posted
- 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 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Drug-coated Balloon With Stent Deployment in Popliteal Atherosclerotic Occlusive Lesions
- ClinicalTrials.gov ID
- NCT03739580
- Acronym / sponsor ID
- DBSP-XWHCMU
- Conditions
- Popliteal Stenosis, Popliteal Artery Occlusion, Diabetes
- Keywords
- drug-coating balloon, stent, popliteal artery, atherosclerotic occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 14 Nov 2018 (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 randomized prospective study aiming to compare drug-coated balloons and stent deployment in Popliteal atherosclerotic occlusive lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drug-coating balloon | Experimental | Device: DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.)drug-coating balloon (Orchid) intervention |
| stent deployment | Active comparator | Device: Stent (Maris,Medtronic.USA or Sinus/Supera, Germany)metal bare stent intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Symptomatic peripheral artery disease:
- Moderate or severe claudication (Rutherford category 2 or 3)
- Critical limb ischemia (Rutherford category 4 or 5)
- Atherosclerotic popliteal artery disease (stenosis > 50%)
Key exclusion criteria (13 listed)
- Acute critical limb ischemia
- Severe critical limb ischemia (Rutherford category 6)
- Involvement of SFA disease with stenosis
- Continous total occlusion of all proximal infrapopliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk).
- Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agent
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 |
|---|---|---|
| DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.)for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment. | Device | drug-coating balloon |
| Stent (Maris,Medtronic.USA or Sinus/Supera, Germany)for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment. | Device | stent deployment |
Primary outcome
Primary patency of claudicant patients
Time frame: 12 months after the index procedure
Claudicant patients (Rutherford C1-3), primary patency defined as PSVR（peak systolic velocity ratio) ≤2.4, absence of restenosis >50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months
Salvage limb rate (for CLI patients)
Time frame: 12 months after the index procedure
Limb Salvage is defined as the freedom from secondary major amputation
7 secondary outcomes
Rutherford classification
Time frame: 12 months
ABI
Time frame: 12 months
TcpO2
Time frame: 12 months
Wagnar classification
Time frame: 12 months
Target vessel revascularization rate
Time frame: 12 months
Index Limb Ischemia at 12-month Follow up
Time frame: 12 months
Major Adverse Events at 12-month Post Procedure
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 14 Nov 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Popliteal Stenosis
Active, not recruiting
First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease
Superficial Femoral Artery Stenosis, Popliteal Artery Stenosis
Not yet recruitingPhase 2/3
A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
Popliteal Artery Disease, Superficial Femoral Artery Disease
Active, not recruitingObservational study
SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
Not yet recruitingObservational study
Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease
Superficial Femoral Artery Stenosis, Iliac Artery Stenosis
Active, not recruiting
The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)
Lower Limb Ischemia, Peripheral Arterial Disease
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.
Yongquan Gu, M.D. principal investigator
Xuanwu hospital CMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.) and Stent (Maris,Medtronic.USA or Sinus/Supera, Germany) in people with Popliteal Stenosis and Popliteal Artery Occlusion, run by Xuanwu Hospital, Beijing 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 6 inclusion and 13 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 14 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianming Guo, M.D. (+86 1314-636-9562, guojianming@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency of claudicant patients (time frame: 12 months after the index procedure). 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 14 Nov 2018.