Vascular DiseasesPhase 4DCLI-INCT01171703
Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part I)
A Phase 4 study testing femoral-popliteal bypass and stent in people with Vascular Diseases and Diabetes, run by Peking Union Medical College Hospital at 3 sites in China.
Trial summary
The purpose of this trial is to find out the appropriate way to treat DM patients with critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Vascular Diseases, Diabetes
- What is being tested?
- femoral-popliteal bypass and stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesChina
- Study dates
- Nov 2010to Jul 2016
- Phase
- Phase 4
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients volunteer to join the trial and sign the formal consent.
- The patients are ≥55 year-old and ≤75 year-old.
- The patients suffer from symptomatic leg ischemia with rutherford classification3, 4 , 5 or 6. The presentation is severe intermittent claudication, rest pain, ulcer or gangrene.
- The lesion of the femoral artery should be TASC B、C or D.
- The femoral-popliteal artery has never received bypass or endovascular therapy before.
- No obvious stenosis or occlusion in the aortoiliac artery; or the lesion could be treated simultaneously or has already been cured.
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- No obvious stenosis in below-knee popliteal artery; at least 1 vessel infra-popliteal runoff to the foot.
- No surgical contraindications;no infection in operation region.
- Be diagnosed with DM for at least 1 year.
Who cannot join
- Refuse random treatment.
- Previous operations on the superficial femoral artery.
- Acute lower extremity arterial thrombosis.
- Serious major organ failure.
- Allergic to the contrast agent or has contrast nephropathy.
- No clinical compliance or unfit to join the trial
Trial locations and contacts
3 sites in 1 country.
China3 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Xuanwu Hospital, Beijing
Beijing, Beijing Municipality, 100053
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part I)
The purpose of this trial is to find out the appropriate way to treat DM patients with critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion.
Read the detailed description
The trial includes two parts and here is part I. This part is a multi-center, prospective, randomized, controlled study to compare the therapeutic effect of stent and bypass to chronic long occlusion of the superficial femoral artery in DM patients. Totally 70 patients will be entered into the study. The lesion of the femoral artery should be TASC B、C or D and the patients should suffered ischemic symptom with Rutherford 3-6.The lesion does not extend beyond the aortoiliac artery or blow-knee popliteal artery, with at least 1 vessel infra-popliteal runoff to the foot.
- Conditions
- Vascular Diseases, Diabetes
- Being tested
- femoral-popliteal bypass, stent
- Keywords
- Critical limb ischemia, Diabetes, Femoropopliteal artery bypass, Stent
- Medical subject headings
- Vascular Diseases, Diabetes Mellitus, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
femoral-popliteal bypassDevice
Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.
stentDevice
Before operation, take aspirin 100mg every day. During the operation, stent is delivered by a catheter and positioned through the narrowing in the artery. The stent is then expanded against the wall of the blood vessel to provide a wider channel for blood. At last, use balloon dilate the stent.
| Study group | Role | What they receive |
|---|---|---|
| bypass | Experimental | femoral-popliteal bypass Receives: Device: femoral-popliteal bypass |
| stent | Experimental | Not described Receives: Device: stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusion of the stent or bypass
Measured: 36 months
Secondary outcomes (5)
Mortality
The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure.
Measured: 30 days
Rate of limb salvage
Measured: 36 months
Procedural complications, defined as any adverse event
including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula
Measured: 36 months
Quality of Life assessment
assessment in 1 month,6 months,12 months,24 months and 36 months post procedure
Measured: 36 months
Restenosis measured by Duplex Ultrasound or CTA
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2013 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tongren Hospital, Xuanwu Hospital, Beijing
- Responsible party
- Principal investigator, Liu Chang-wei, Peking Union Medical College Hospital
- Investigators
- Liu changwei, bachelor, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171703
- Sponsor's protocol ID
- pumch-DCLI-I
- Acronym
- DCLI-I
- Status last verified
- Jul 2010
- First submitted
- 26 Jul 2010
- Last updated
- 24 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part I)
- ClinicalTrials.gov ID
- NCT01171703
- Acronym / sponsor ID
- DCLI-I / pumch-DCLI-I
- Conditions
- Vascular Diseases, Diabetes
- Keywords
- Critical limb ischemia, Diabetes, Femoropopliteal artery bypass, Stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Tongren Hospital, Xuanwu Hospital, Beijing
- Study start
- Nov 2010
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 28 Jul 2010 (estimated)
- 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 purpose of this trial is to find out the appropriate way to treat DM patients with critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion.
Detailed description
The trial includes two parts and here is part I. This part is a multi-center, prospective, randomized, controlled study to compare the therapeutic effect of stent and bypass to chronic long occlusion of the superficial femoral artery in DM patients. Totally 70 patients will be entered into the study. The lesion of the femoral artery should be TASC B、C or D and the patients should suffered ischemic symptom with Rutherford 3-6.The lesion does not extend beyond the aortoiliac artery or blow-knee popliteal artery, with at least 1 vessel infra-popliteal runoff to the foot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bypass | Experimental | Device: femoral-popliteal bypassfemoral-popliteal bypass |
| stent | Experimental | Device: stent |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patients volunteer to join the trial and sign the formal consent.
- The patients are ≥55 year-old and ≤75 year-old.
- The patients suffer from symptomatic leg ischemia with rutherford classification3, 4 , 5 or 6. The presentation is severe intermittent claudication, rest pain, ulcer or gangrene.
- The lesion of the femoral artery should be TASC B、C or D.
- The femoral-popliteal artery has never received bypass or endovascular therapy before.
Key exclusion criteria (6 listed)
- Refuse random treatment.
- Previous operations on the superficial femoral artery.
- Acute lower extremity arterial thrombosis.
- Serious major organ failure.
- Allergic to the contrast agent or has contrast nephropathy.
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 |
|---|---|---|
| femoral-popliteal bypassBefore operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses. | Device | bypass |
| stentBefore operation, take aspirin 100mg every day. During the operation, stent is delivered by a catheter and positioned through the narrowing in the artery. The stent is then expanded against the wall of the blood vessel to provide a wider channel for blood. At last, use balloon dilate the stent. | Device | stent |
Primary outcome
Occlusion of the stent or bypass
Time frame: 36 months
5 secondary outcomes
Mortality
Time frame: 30 days
Rate of limb salvage
Time frame: 36 months
Procedural complications, defined as any adverse event
Time frame: 36 months
Quality of Life assessment
Time frame: 36 months
Restenosis measured by Duplex Ultrasound or CTA
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2012.
- the website of the vascular surgery department of PUMCHLink provided by the sponsor.
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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.
Liu changwei, bachelor study chair
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing femoral-popliteal bypass and stent in people with Vascular Diseases and Diabetes, run by Peking Union Medical College Hospital at 3 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 9 inclusion and 6 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 24 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Occlusion of the stent or bypass (time frame: 36 months). 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 24 Dec 2012.