Arterial Occlusive DiseasesPhase 4SPACIALNCT01147419
Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery
A Phase 4 study testing stent and femoral-popliteal bypass with artificial blood vessel in people with Arterial Occlusive Diseases and Vascular Diseases, run by Peking Union Medical College Hospital at 3 sites in China.
Trial summary
Different strategies exist in the treatment of chronic long occlusion of the superficial femoral artery. Traditionally, these patients should be treated with bypass. If the great saphenous vein is unavailable, doctor has to choose artificial vessel as graft. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Arterial Occlusive Diseases, Vascular Diseases
- What is being tested?
- stent and femoral-popliteal bypass with artificial blood vessel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesChina
- Study dates
- Jun 2010to Jun 2015
- 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 45 to 80 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 ≥45 year-old and ≤80 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 total length of the femoral and popliteal artery lesion(including ≥75% stenosis and occlusion) are at least 15cm.
- 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.
- No available saphenous vein.
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, 3 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Liu Changwei, bachelor, 86-010-88068230, liucw@vip.sina.com
Ye Wei, doctor, 86-010-88068230, yewill18@gmail.com
- Recruiting
Xuanwu Hospital, Beijing
Beijing, Beijing Municipality, 100053
Gu Yongquan, doctor
Gu Yongquan, doctor
- Recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730
Yu Zhengya, doctor, zhengyayu@yahoo.com
Yu Zhengya, doctor
About this study
Official title: The Study to Compare the Treatment of Stent and Prothesis Bypass in SFA Occlusions
Different strategies exist in the treatment of chronic long occlusion of the superficial femoral artery. Traditionally, these patients should be treated with bypass. If the great saphenous vein is unavailable, doctor has to choose artificial vessel as graft. Now, the skill of endovascular treatment is developing rapidly, and lots of doctors think most of such patients could be treated with stent. The purpose of this trial is to compare stent and artificial blood vessel bypass in the treatment of long occlusion of the superficial femoral artery. The study hypothesis is that patency rates are comparable and therefore the minimal invasive treatment of stent can be considered in such patients.
Read the detailed description
This is a multi-center, prospective, randomized, controlled trial to compare the therapeutic effect of stent and artificial blood vessel bypass to chronic long occlusion of the superficial femoral artery. Totally 200 patients will be entered into the trial. The study population will consist of patients with long superficial femoral stenosis and occlusion lesion (≥15 cm), presenting symptomatic ischemia（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.
Trial participants will be randomized to either stent group or artificial blood vessel bypass group.
Patients will be followed up for 3 years. Study examinations will be done at screening, procedure time, 1, 6, 12, 24 and 36 months after procedure.
This study will be conducted at 3 centers in Beijing, China.
- Conditions
- Arterial Occlusive Diseases, Vascular Diseases
- Being tested
- stent, femoral-popliteal bypass with artificial blood vessel
- Keywords
- critical limb ischemia, peripheral artery occlusive disease, femoropopliteal artery bypass, Stent
- Medical subject headings
- Arterial Occlusive Diseases, Vascular Diseases, Chronic Limb-Threatening Ischemia, Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
femoral-popliteal bypass with artificial blood vesselDevice
Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.
| Study group | Role | What they receive |
|---|---|---|
| bypass | Experimental | Patients presenting with long occlusion of the superficial femoral artery enrolled in bypass arm will undergo suprageniculate femoropopliteal bypass surgery to bypass the occluded superficial femoral artery. And the graft will be artificial blood vessel. Receives: Device: femoral-popliteal bypass with artificial blood vessel |
| 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 artificial blood vessel bypass
Measured: 36 months
Secondary outcomes (7)
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
Rate of amputation
Measured: 36 months
Increase in Ankle Brachial Index
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 posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Occlusive 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
- 200 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
- Investigators
- Liu Changwei, bachelor, Study chairYe Wei, doctor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147419
- Sponsor's protocol ID
- pumch-vascular surgery
- Acronym
- SPACIAL
- Status last verified
- Jul 2010
- First submitted
- 16 Jun 2010
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study to Compare the Treatment of Stent and Prothesis Bypass in SFA Occlusions
- ClinicalTrials.gov ID
- NCT01147419
- Acronym / sponsor ID
- SPACIAL / pumch-vascular surgery
- Conditions
- Arterial Occlusive Diseases, Vascular Diseases
- Keywords
- critical limb ischemia, peripheral artery occlusive disease, femoropopliteal artery bypass, Stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Tongren Hospital, Xuanwu Hospital, Beijing
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 22 Jun 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.
Different strategies exist in the treatment of chronic long occlusion of the superficial femoral artery. Traditionally, these patients should be treated with bypass. If the great saphenous vein is unavailable, doctor has to choose artificial vessel as graft. Now, the skill of endovascular treatment is developing rapidly, and lots of doctors think most of such patients could be treated with stent. The purpose of this trial is to compare stent and artificial blood vessel bypass in the treatment of long occlusion of the superficial femoral artery. The study hypothesis is that patency rates are comparable and therefore the minimal invasive treatment of stent can be considered in such patients.
Detailed description
This is a multi-center, prospective, randomized, controlled trial to compare the therapeutic effect of stent and artificial blood vessel bypass to chronic long occlusion of the superficial femoral artery. Totally 200 patients will be entered into the trial. The study population will consist of patients with long superficial femoral stenosis and occlusion lesion (≥15 cm), presenting symptomatic ischemia（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.
Trial participants will be randomized to either stent group or artificial blood vessel bypass group.
Patients will be followed up for 3 years. Study examinations will be done at screening, procedure time, 1, 6, 12, 24 and 36 months after procedure.
This study will be conducted at 3 centers in Beijing, China.
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 bypass with artificial blood vesselPatients presenting with long occlusion of the superficial femoral artery enrolled in bypass arm will undergo suprageniculate femoropopliteal bypass surgery to bypass the occluded superficial femoral artery. And the graft will be artificial blood vessel. |
| stent | Experimental | Device: stent |
Who may qualify
- Ages
- 45 to 80 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 ≥45 year-old and ≤80 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 total length of the femoral and popliteal artery lesion(including ≥75% stenosis and occlusion) are at least 15cm.
- 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 |
|---|---|---|
| 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 |
| femoral-popliteal bypass with artificial blood vesselBefore operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses. | Device | bypass |
Primary outcome
Occlusion of the stent or artificial blood vessel bypass
Time frame: 36 months
7 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
Rate of amputation
Time frame: 36 months
Increase in Ankle Brachial Index
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 7 Jul 2010.
- 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
Ye Wei, doctor principal investigator
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 stent and femoral-popliteal bypass with artificial blood vessel in people with Arterial Occlusive Diseases and Vascular Diseases, 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 7 Jul 2010. 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?
Contact Liu Changwei, bachelor (86-010-88068230, liucw@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusion of the stent or artificial blood vessel 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 7 Jul 2010.