Arterial Occlusive DiseasesPhase 2/3NCT00156624
Thunder Trial - Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries
A Phase 2/3 study testing Balloon Angioplasty with or without drug administration in people with Arterial Occlusive Diseases, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The Thunder Trail is a randomized , double-blinded, placebo controlled German multi-centre study on the efficacy of local paclitaxel for prevention of restenosis in the superficial and popliteal artery. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Arterial Occlusive Diseases
- What is being tested?
- Balloon Angioplasty with or without drug administration
- How many people
- 135 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2004to Oct 2007
- Phase
- Phase 2/3
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults
- Chronic Occlusions and stenosis (history at least 6 weeks) ≥70 % diameter Stenosis > 2cm in the arteria femoralis superficialis or arteria poplitea
- Various criteria assuring ethical issues and follow up
Who cannot join
- Conditions requiring different treatment or raising serious safety concern regarding the procedure or the required medication.
- Pregnancy can not be excluded
- Doubts in the willingness or capability of the patient to allow 6 months follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries (Thunder - Trial)
The Thunder Trail is a randomized , double-blinded, placebo controlled German multi-centre study on the efficacy of local paclitaxel for prevention of restenosis in the superficial and popliteal artery.
Read the detailed description
Drug eluting stents have been proven to reduce the restenosis rate in the coronary arteries. Unfortunately drug eluting stents failed to demonstrate superiority over bare stents in the superficial femoral artery. We could show that a non-stent based delivery of Taxan was equal or superior to drug eluting stents in an animal model. This was both true for the coronary arteries and peripheral vessels.
In a prospective blinded trail >135 patients are randomized either to receive Taxan locally administered with a balloon catheter during balloon angioplasty, or together with contrast media. One group serves as control. There were no limitations due to lesion length. Follow-up angiography will be after 6 months, 12 months and 2 years.
- Conditions
- Arterial Occlusive Diseases
- Being tested
- Balloon Angioplasty with or without drug administration
- Keywords
- Intervention, Peripheral Vascular Disease, Drug, Restenosis, 18 years and above
- Medical subject headings
- Arterial Occlusive Diseases, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon Angioplasty with or without drug administrationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Late lumen loss of vessel segment following dilatation after 6 months
Secondary outcomes (2)
Thrombotic complications or revascularization of the target vessel, death; adverse reactions known to occur after paclitaxel (high dose tumor therapy except reactions to the detergent)
Paclitaxel plasma concentration will be determined immediately after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2004
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Arterial Occlusive DiseasesStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 135 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Herzzentrum Bad Krotzingen, Humboldt-Universität zu Berlin, University of Greifswald
- Investigators
- Gunnar Tepe, MD, Principal investigator, University Hospital of TuebingenGunnar Tepe, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156624
- Sponsor's protocol ID
- Pac-2
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 25 Apr 2006
- Results posted
- No
Publications
Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
PubMed 42573020Tepe G, Schnorr B, Albrecht T, Brechtel K, Claussen CD, Scheller B, Speck U, Zeller T. Angioplasty of femoral-popliteal arteries with drug-coated balloons: 5-year follow-up of the THUNDER trial. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):102-8. doi: 10.1016/j.jcin.2014.07.023.
PubMed 25616822Tepe G, Zeller T, Schnorr B, Claussen CD, Beschorner U, Brechtel K, Scheller B, Speck U. High-grade, non-flow-limiting dissections do not negatively impact long-term outcome after paclitaxel-coated balloon angioplasty: an additional analysis from the THUNDER study. J Endovasc Ther. 2013 Dec;20(6):792-800. doi: 10.1583/13-4392R.1.
PubMed 24325695Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.
PubMed 18272892
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries (Thunder - Trial)
- ClinicalTrials.gov ID
- NCT00156624
- Acronym / sponsor ID
- Pac-2
- Conditions
- Arterial Occlusive Diseases
- Keywords
- Intervention, Peripheral Vascular Disease, Drug, Restenosis, 18 years and above
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Herzzentrum Bad Krotzingen, Humboldt-Universität zu Berlin, University of Greifswald
- Study start
- Jul 2004
- Study completion
- Oct 2007
- First posted
- 12 Sep 2005 (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 Thunder Trail is a randomized , double-blinded, placebo controlled German multi-centre study on the efficacy of local paclitaxel for prevention of restenosis in the superficial and popliteal artery.
Detailed description
Drug eluting stents have been proven to reduce the restenosis rate in the coronary arteries. Unfortunately drug eluting stents failed to demonstrate superiority over bare stents in the superficial femoral artery. We could show that a non-stent based delivery of Taxan was equal or superior to drug eluting stents in an animal model. This was both true for the coronary arteries and peripheral vessels.
In a prospective blinded trail >135 patients are randomized either to receive Taxan locally administered with a balloon catheter during balloon angioplasty, or together with contrast media. One group serves as control. There were no limitations due to lesion length. Follow-up angiography will be after 6 months, 12 months and 2 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults
- Chronic Occlusions and stenosis (history at least 6 weeks) ≥70 % diameter Stenosis > 2cm in the arteria femoralis superficialis or arteria poplitea
- Various criteria assuring ethical issues and follow up
Key exclusion criteria (3 listed)
- Conditions requiring different treatment or raising serious safety concern regarding the procedure or the required medication.
- Pregnancy can not be excluded
- Doubts in the willingness or capability of the patient to allow 6 months follow up
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 Angioplasty with or without drug administration | Drug | – |
Primary outcome
Late lumen loss of vessel segment following dilatation after 6 months
2 secondary outcomes
Thrombotic complications or revascularization of the target vessel, death; adverse reactions known to occur after paclitaxel (high dose tumor therapy except reactions to the detergent)
Paclitaxel plasma concentration will be determined immediately after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2006.
- Derived from this study: PubMed 42573020Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
- Derived from this study: PubMed 25616822Tepe G, Schnorr B, Albrecht T, Brechtel K, Claussen CD, Scheller B, Speck U, Zeller T. Angioplasty of femoral-popliteal arteries with drug-coated balloons: 5-year follow-up of the THUNDER trial. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):102-8. doi: 10.1016/j.jcin.2014.07.023.
- Derived from this study: PubMed 24325695Tepe G, Zeller T, Schnorr B, Claussen CD, Beschorner U, Brechtel K, Scheller B, Speck U. High-grade, non-flow-limiting dissections do not negatively impact long-term outcome after paclitaxel-coated balloon angioplasty: an additional analysis from the THUNDER study. J Endovasc Ther. 2013 Dec;20(6):792-800. doi: 10.1583/13-4392R.1.
- Derived from this study: PubMed 18272892Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.
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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.
Gunnar Tepe, MD principal investigator
University Hospital of Tuebingen
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 2/3 study testing Balloon Angioplasty with or without drug administration in people with Arterial Occlusive Diseases, 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 3 inclusion and 3 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 25 Apr 2006. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Late lumen loss of vessel segment following dilatation after 6 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00156624, which also lists 4 linked publications.
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 25 Apr 2006.