StenosisSAMBANCT03149913
Local Paclitaxel or Balloon Angioplasty Below the Knee
A study testing SequentPlease OTW paclitaxel coated balloon catheter and conventional uncoated balloon for BTK endovascular therapy in people with Stenosis and Occlusion, run by Prof. Dr. med. Gunnar Tepe at 7 sites in 2 countries.
Trial summary
Patients with claudication or critical limb ischemia will be treated either with uncoated balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or occluded below the knee arteries Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stenosis, Occlusion, Restenosis
- What is being tested?
- SequentPlease OTW paclitaxel coated balloon catheter and conventional uncoated balloon for BTK endovascular therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 15 Dec 2016to Jul 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Chronic stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries
- Rutherford 2-5 patients
- Patients with ≤ 2 BTK lesions (≥ 70% diameter stenosis)
- Lesion length limited to 5-25 cm
Who cannot join
- Planned or foreseeable amputation
- Previous amputation at the index limb
- Index vessel with no run-off to the foot distal to the index lesion
- Prior treatment of the index lesion with a drug coated balloon
- In-stent restenosis
- Life expectancy <1 year
Show all 11Show fewer
- Known creatinine >1.4 mg% if patient is not on dialysis
- Acute thrombus in the index limb
- Aneurysm in the index leg
- Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel
- Patients with concomitant medical illnesses that require cytostatic or radiation therapy
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Germany6 sites, 6 recruiting
- Not yet recruiting
Klinikum Arnsberg
Arnsberg
M. Lichtenberg, MD
M Lichtenberg
- Not yet recruiting
Herzzentrum Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, 73000
Thomas Zeller, MD, 076334022431, thomas.zeller@herzzentrum.de
Thomas Zeller, MD
- Not yet recruiting
Ev.-Luth. Diakonissenanstalt zu Flensburg
Flensburg
S. Mueller-Huelsbeck, MD
- Not yet recruiting
Evangelisches Krankenhaus Mülheim a. d. Ruhr
Mülheim, 45468
C. Nolte-Ernsting, MD
- Recruiting
Tepe
Rosenheim, Baden-Wurttemberg, 83022
Gunnar Tepe, MD, 80313653551, gunnar.tepe@ro-med.de
Gunnar Tepe, MD
- Not yet recruiting
Universitätsklinikum Würzburg
Würzburg
R. Kickuth, MD
Austria1 site, 1 recruiting
- Not yet recruiting
LKH-Univ. Klinikum Graz
Graz
M. Brodmann, MD
About this study
Official title: Does Local Paclitaxel Improve the Efficacy of Balloon Angioplasty Without Stent Implantation for Treatment of Below the Knee Artery Lesions?
Patients with claudication or critical limb ischemia will be treated either with uncoated balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or occluded below the knee arteries
Read the detailed description
After successful guide wire passage of the below the knee index lesions the patients will either receive a treatment with a conventional uncoated balloon or a balloon coated with paclitaxel. Only patients who require follow-up angiography after 6 months will be included in this study. The primary endpoint (index vessel occluded or still open) is at 6 months - the patients will be also followed for 24 months for clinical endpoints. In addition an MRI is planned at 12 months.
- Conditions
- Stenosis, Occlusion, Restenosis
- Being tested
- SequentPlease OTW paclitaxel coated balloon catheter, conventional uncoated balloon for BTK endovascular therapy
- Keywords
- below the knee artery, endovascular, drug coated balloon, critical limb ischemia
- Medical subject headings
- Constriction, Pathologic, Bites and Stings, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SequentPlease OTW paclitaxel coated balloon catheterDevice
PTA with SequentPlease OTW paclitaxel coated balloon catheter
conventional uncoated balloon for BTK endovascular therapyDevice
PTA with uncoated balloon for BTK endovascular therapy
| Study group | Role | What they receive |
|---|---|---|
| Drug coated balloon | Experimental | SeQuentPlease OTW paclitaxel coated balloon catheter Receives: Device: SequentPlease OTW paclitaxel coated balloon catheter |
| uncoated PTA balloon catheter | Active comparator | Standard of care uncoated BTK balloon catheter Receives: Device: conventional uncoated balloon for BTK endovascular therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusion rate of the target lesion at 6 months
by digital substraction angiogram or MRI
Measured: 6 +/- 1 months
Secondary outcomes (1)
target lesion revascularization
repeat intervention
Measured: 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start15 Dec 2016
- Primary completion30 Dec 2018 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- The vessel patency (measured by angiography at 6 months) will be compared after patients have been treated either with paclitaxel coated or uncoated balloons (control) in BTK arteries
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Gunnar Tepe
- Sponsor type
- University, hospital or other
- Collaborators
- InnoRa GmbH
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Gunnar Tepe, Klinikum Rosenheim
- Investigators
- Gunnar Tepe, MD, Principal investigator, RoMed Klinikum Rosenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149913
- Sponsor's protocol ID
- BTK 1
- Acronym
- SAMBA
- Status last verified
- May 2017
- First submitted
- 30 Mar 2017
- Last updated
- 11 May 2017
- 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 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Local Paclitaxel Improve the Efficacy of Balloon Angioplasty Without Stent Implantation for Treatment of Below the Knee Artery Lesions?
- ClinicalTrials.gov ID
- NCT03149913
- Acronym / sponsor ID
- SAMBA / BTK 1
- Conditions
- Stenosis, Occlusion, Restenosis
- Keywords
- below the knee artery, endovascular, drug coated balloon, critical limb ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Prof. Dr. med. Gunnar TepeUniversity, hospital or other
- Collaborators
- InnoRa GmbH
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 11 May 2017 (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.
Patients with claudication or critical limb ischemia will be treated either with uncoated balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or occluded below the knee arteries
Detailed description
After successful guide wire passage of the below the knee index lesions the patients will either receive a treatment with a conventional uncoated balloon or a balloon coated with paclitaxel. Only patients who require follow-up angiography after 6 months will be included in this study. The primary endpoint (index vessel occluded or still open) is at 6 months - the patients will be also followed for 24 months for clinical endpoints. In addition an MRI is planned at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The vessel patency (measured by angiography at 6 months) will be compared after patients have been treated either with paclitaxel coated or uncoated balloons (control) in BTK arteries
| Arm | Type | Receives |
|---|---|---|
| Drug coated balloon | Experimental | Device: SequentPlease OTW paclitaxel coated balloon catheterSeQuentPlease OTW paclitaxel coated balloon catheter |
| uncoated PTA balloon catheter | Active comparator | Device: conventional uncoated balloon for BTK endovascular therapyStandard of care uncoated BTK balloon catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years of age
- Chronic stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries
- Rutherford 2-5 patients
- Patients with ≤ 2 BTK lesions (≥ 70% diameter stenosis)
- Lesion length limited to 5-25 cm
Key exclusion criteria (11 listed)
- Planned or foreseeable amputation
- Previous amputation at the index limb
- Index vessel with no run-off to the foot distal to the index lesion
- Prior treatment of the index lesion with a drug coated balloon
- In-stent restenosis
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 |
|---|---|---|
| SequentPlease OTW paclitaxel coated balloon catheterPTA with SequentPlease OTW paclitaxel coated balloon catheter | Device | Drug coated balloon |
| conventional uncoated balloon for BTK endovascular therapyPTA with uncoated balloon for BTK endovascular therapy | Device | uncoated PTA balloon catheter |
Primary outcome
Occlusion rate of the target lesion at 6 months
Time frame: 6 +/- 1 months
by digital substraction angiogram or MRI
1 secondary outcome
target lesion revascularization
Time frame: 3, 6, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
Related trials for Stenosis
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
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
RoMed Klinikum Rosenheim
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SequentPlease OTW paclitaxel coated balloon catheter and conventional uncoated balloon for BTK endovascular therapy in people with Stenosis and Occlusion, run by Prof. Dr. med. Gunnar Tepe at 7 sites in 2 countries.
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 11 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 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Austria. 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 Gunnar Tepe, MD (+498031365 ext. 3551, gunnar.tepe@ro-med.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusion rate of the target lesion at 6 months (time frame: 6 +/- 1 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 11 May 2017.