Cronic Limb IshemiaPhase 4XXSNCT00546845
Balloon Angioplasty Versus Xpert Stent in CLI Patients XXS Study
A Phase 4 study testing Balloon angioplasty and Use of self-expanding Expert stent in people with Cronic Limb Ishemia and Intervention, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This study is an investigator-initiated study. The study will be performed as a prospective, randomized, controlled multi-center trial to evaluate the safety and efficiency of Xpert stents compared to PTA in patients with chronic distal artery occlusions or stenosis undergoing catheter revascularization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cronic Limb Ishemia, Intervention
- What is being tested?
- Balloon angioplasty and Use of self-expanding Expert stent
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Jun 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical:
- 1. Age between 18 and 95 years. 2. Subject or subject's legal representative have been informed of the nature of the study, and have signed the patient informed consent form. Patient is willing to take part in the follow-up protocol of the XXS study.
- 3. Rutherford stage 4 and 5 Anatomical:
- Additional lesions inflow lesions might be successfully treated before randomization and treatment of the target lesion. The inflow lesions which were treated before randomization should only be classified TASC A or B. (TASC= Trans Atlantic Intersociety Conference)
- Target vessel with documented run-off to the foot distally of the index lesion with patent plantar arteries
- Reference vessel diameter of the target lesion should be ≥ 2 and ≤ 5 mm.
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- Maximum treated length in the target vessel is 15 cm (might also be divided up into multiple segments with up to 3 different lesions being treated).
- Maximum of treated vessels per leg below the knee: 2 (all treated vessels should be treated within the randomization to the study group [PTA or stenting]).
- Minimum distance target lesion to talus is 5 cm.
Who cannot join
- Clinical
- Life expectancy due to a non-atheroslerotic disease less than 12 months.
- Previous bypass surgery < 30 days prior to the study procedure.
- Known allergies or sensitivities to heparin, contrast media, aspirin, clopidogrel, and nitinol which cannot be treated with antihistamines.
- eGFR less than 29 mL/min/1.73m2 (K-DOQI Class 4 and 5) in patients which are not currently treated with dialysis (equivalent to a serum creatinine level of 2.4 mg/dL in a 70 year old male patient)
- Subject with breast feeding plans, or child bearing potential with no birth control.
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- Subjects enrolled in another study concerning the index vessel(s) within 3 months prior to the study procedure.
- Untreatable bleeding diatheses.
- Patients who have an indication of being treated with coumadin after the intervention.
- Inability to ambulate
- Hypercoagulable state
- Patients with age <18 years and patients who are not able to sign the informed consent form
- Anatomical:
- Inflow is obstructed and cannot be successfully treated prior to randomization and treatment of below the knee arteries.
- Acute thrombus present in the target limb.
- Previously implanted stent in the target vessel(s).
- Aneurysms in the index leg.
- Index vessel with no documented run-up to the foot (please also see inclusion criteria, anatomical).
- Inability to use femoral access
- No patent pedal arteries
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universtiy of Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Gunnar Tepe, MD, 49 7071 2983371, gunnar.tepe@med.uni-tuebingen.de
Thomas Zeller, MD
About this study
Official title: Xpert Stent Versus Balloon Angioplasty in Complex Lesions of Small Arteries Below the Knee
This study is an investigator-initiated study. The study will be performed as a prospective, randomized, controlled multi-center trial to evaluate the safety and efficiency of Xpert stents compared to PTA in patients with chronic distal artery occlusions or stenosis undergoing catheter revascularization. Patients will be eligible for randomization if they are over 18 years old, if they undergo percutaneous catheter revascularization of an artery below the knee stenosis/occlusion that is less than 15 centimeters in length. Up to two vessels may be treated in this study. All lesions greater than 50% in the below the knee artery region have to be treated either with PTA or stenting according to the randomization.
- Conditions
- Cronic Limb Ishemia, Intervention
- Being tested
- Balloon angioplasty, Use of self-expanding Expert stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon angioplastyDevice
Balloon angioplasty. Only stent if PTA fails
Use of self-expanding Expert stentDevice
Nitinol stent
What is being measured
The primary outcome is the main question the study is designed to answer.
MLD at the target lesion assessed by angiography
treatment effect dependent if stent of PTA was choosen
Measured: after 12 +/-2 months
Secondary outcomes (4)
1. Interventional success rate. Interventional success is defined as restenosis less than 50%. 2. Late lumen loss (LLL)
treatment effect dependent on the PTA vs. Stent
Measured: after 1, 6, 12 months and 3 years
3. Binary restenosis
Treament effect in long-term
Measured: arter 6, 12 months and 3 years
4. Number of patients initially randomized to the PTA group, but receiving stents because of the suboptimal interventional success.
success rate of PTA only
Measured: intervention
Target lesion revascularization, clinical stage, hospital days
treatment effect dependet if patients received stents or PTA only
Measured: after 1, 6, 12 months, and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2012 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cronic Limb IshemiaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Gunnar Tepe, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546845
- Sponsor's protocol ID
- XXS
- Acronym
- XXS
- Status last verified
- Oct 2007
- First submitted
- 17 Oct 2007
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xpert Stent Versus Balloon Angioplasty in Complex Lesions of Small Arteries Below the Knee
- ClinicalTrials.gov ID
- NCT00546845
- Acronym / sponsor ID
- XXS / XXS
- Conditions
- Cronic Limb Ishemia, Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 19 Oct 2007 (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.
This study is an investigator-initiated study. The study will be performed as a prospective, randomized, controlled multi-center trial to evaluate the safety and efficiency of Xpert stents compared to PTA in patients with chronic distal artery occlusions or stenosis undergoing catheter revascularization. Patients will be eligible for randomization if they are over 18 years old, if they undergo percutaneous catheter revascularization of an artery below the knee stenosis/occlusion that is less than 15 centimeters in length. Up to two vessels may be treated in this study. All lesions greater than 50% in the below the knee artery region have to be treated either with PTA or stenting according to the randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Age between 18 and 95 years. 2. Subject or subject's legal representative have been informed of the nature of the study, and have signed the patient informed consent form. Patient is willing to take part in the follow-up protocol of the XXS study.
- Additional lesions inflow lesions might be successfully treated before randomization and treatment of the target lesion. The inflow lesions which were treated before randomization should only be classified TASC A or B. (TASC= Trans Atlantic Intersociety Conference)
- Target vessel with documented run-off to the foot distally of the index lesion with patent plantar arteries
- Reference vessel diameter of the target lesion should be ≥ 2 and ≤ 5 mm.
- Maximum treated length in the target vessel is 15 cm (might also be divided up into multiple segments with up to 3 different lesions being treated).
Key exclusion criteria (20 listed)
- Clinical
- Inflow is obstructed and cannot be successfully treated prior to randomization and treatment of below the knee arteries.
- Acute thrombus present in the target limb.
- Previously implanted stent in the target vessel(s).
- Aneurysms in the index leg.
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 |
|---|---|---|
| Balloon angioplastyBalloon angioplasty. Only stent if PTA fails | Device | – |
| Use of self-expanding Expert stentNitinol stent | Device | – |
Primary outcome
MLD at the target lesion assessed by angiography
Time frame: after 12 +/-2 months
treatment effect dependent if stent of PTA was choosen
4 secondary outcomes
1. Interventional success rate. Interventional success is defined as restenosis less than 50%. 2. Late lumen loss (LLL)
Time frame: after 1, 6, 12 months and 3 years
3. Binary restenosis
Time frame: arter 6, 12 months and 3 years
4. Number of patients initially randomized to the PTA group, but receiving stents because of the suboptimal interventional success.
Time frame: intervention
Target lesion revascularization, clinical stage, hospital days
Time frame: after 1, 6, 12 months, and 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
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.
Gunnar Tepe, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Balloon angioplasty and Use of self-expanding Expert stent in people with Cronic Limb Ishemia and Intervention, run by University Hospital Tuebingen at 1 site in Germany.
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 20 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 8 Aug 2011. 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 Germany. 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 Gunnar Tepe, MD (49 7071 2983371, gunnar.tepe@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MLD at the target lesion assessed by angiography (time frame: after 12 +/-2 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 8 Aug 2011; AzTrials last refreshed its copy on 6 Nov 2026.