AtherosclerosisPhase 2/3PiccoloNCT00696956
Drug Coated Balloons for Prevention of Restenosis
A Phase 2/3 study testing Balloon angioplasty (uncoated conventional balloon) and Balloon angioplasty (conventional but coated with 3 µg/mm2 paclitaxel) in people with Atherosclerosis and Restenosis, run by University Hospital Tuebingen at 5 sites in Germany.
Trial summary
The study will be performed as a randomized, double blind trial (in respect of the primary end point) with treatment of the stenotic lesion using uncoated PTA-catheters as control group. 114 patients will be included in the trial at about 5 study centers. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Atherosclerosis, Restenosis, Limb Ishemia
- What is being tested?
- Balloon angioplasty (uncoated conventional balloon) and Balloon angioplasty (conventional but coated with 3 µg/mm2 paclitaxel)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 5 sitesGermany
- Study dates
- Apr 2008to Apr 2011
- 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
- Age between 18 and 95 years,
- peripheral vascular disease, Rutherford stage 3-5, diameter stenosis ≥ 70 %, ≥ 15 -150 mm length, up to 2 vessels to be treated
Who cannot join
- Disease associated with life-expectancy less than 18 months
- Acute thrombus or aneurysm in the index limb/ vessel
- Doubts in the willingness or capability of the patient to allow follow up examination
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites, 2 recruiting
- Recruiting
Herzzentrum Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, 76551
Thomas Zeller, MD, thomas.zeller@herzzentrum.de
- Active, not recruiting
Charite Berlin
Berlin, B, 10001
- Active, not recruiting
Jüdisches Krankenhaus Berlin
Berlin, B, 10001
- Active, not recruiting
University of Rostock
Rostock, MP, 01065
- Recruiting
University of Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Gunnar Tepe, MD, 49-707-129 ext. 83371, gunnar.tepe@med.uni-tuebingen.de
Gunnar Tepe, MD
About this study
Official title: Paclitaxel Coated Balloons for Prevention of Restenosis in Small Arteries Below the Knee Compared to Angioplasty Using Uncoated Balloons
The study will be performed as a randomized, double blind trial (in respect of the primary end point) with treatment of the stenotic lesion using uncoated PTA-catheters as control group. 114 patients will be included in the trial at about 5 study centers. Follow-up includes control angiography after 6 and 18 months and clinical follow-up examinations up to 18 months. Primary objective:
Efficacy of paclitaxel coated PTA balloons in inhibiting restenosis of below the knee arteries (late lumen loss)
Read more
Secondary objective:
Various angiographic and clinical efficacy measures, safety and tolerance of pacli-taxel coated PTA balloons in inhibiting restenosis of below the knee arteries Descriptive statistics, comparison by t-test, chi-square test for binary events 10.1 Descriptive statistics As far as applicable descriptive statistics will be applied to data and will be referring to individual changes versus baseline (predilatation or immediately postdilatation). The groups will be compared to each other testing the statistical significance of differences (p ≤ 0.05). Con-tinuous data will be expressed as mean ± standard deviation.
Categorical variables will be compared using the chi-squared test, and continuous variables will be compared using Student's t test or ANOVA analysis.
In addition to the assessment of the primary endpoint and the secondary endpoints a multi-variate analysis to investigate the influence of risk factors on the interventional outcome (interventional success, early restenosis/occlusion, LLL, stent integrity) and clinical outcomes will be performed. For this analysis the following factors will be considered: age, diabetes, neurological status (only Rutherford 5), lesion length, grade of dissection and calcification, reststenosis, number of run-off vessels, stent administration in the index lesion(s).
10.2 Estimated number of patients The primary endpoint of the study is late lumen loss (LLL) at 6 months evaluated by quantitative angiography. Because no data according this endpoint are available for both the control group and the group which will be treated with the paclitaxel coated balloon an assumption according the LLL at 6 months was made according the expectations of the principle investigator. An estimate for LLL as % of MLD in the control group is 50% and in the drug coated balloon group 30 %. The standard deviation is calculated to be 30% of LLL. A sample size of 37 patients in each group will allow the detection of a statistically significant difference (p<0.05) with 80% power. Based on the "Below study" which enrolled patients with comparable arterial lesions in Tuebingen and the data of the Basil study, it is estimated that 35% of the patients who will be enrolled in the study will not be available for follow-up investigations in order to calculate the MLD.
In order to meet a statistical endpoint a total of 114 patients will be enrolled.
- Conditions
- Atherosclerosis, Restenosis, Limb Ishemia
- Being tested
- Balloon angioplasty (uncoated conventional balloon), Balloon angioplasty (conventional but coated with 3 µg/mm2 paclitaxel)
- Keywords
- local drug delivery, balloon angioplasty, safety and tolerance of paclitaxel coated PTA balloons, in inhibiting restenosis of below the knee arteries, Efficacy of paclitaxel coated PTA balloons, in inhibiting restenosis of below the knee arteries (late lumen loss)
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon angioplasty (uncoated conventional balloon)Device
endovascular therapy
Balloon angioplasty (conventional but coated with 3 µg/mm2 paclitaxel)Device
endovascular therapy
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Normal balloon for balloon angioplasty (Submarine, Ampherion Deep by Invatec) Receives: Device: Balloon angioplasty (uncoated conventional balloon) |
| 2 | Active comparator | Paclitaxel coated balloon (same balloon like in the control group, but coated with 3 µg/mm2 Paclitaxel) Receives: Device: Balloon angioplasty (conventional but coated with 3 µg/mm2 paclitaxel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint: Late lumen loss (LLL) of the target lesion after 6 months (assessed by DSA)
Measured: after 6 months
Secondary outcomes (16)
Interventional success rate (defined as reststenosis less than 50%)
Measured: up to 18 months
Restenosis rate at 6 and 18 months (restenosis rate is defined as a diameter stenosis of ≥ 50% of reference diameter
Measured: up to 18 months
Minimum lumen diameter (MLD) at 6 months
Measured: up to 18 months
Target lesion revascularization recorded at 6, 12 and 18 months; target lesion revascularization is defined as any reintervention or artery bypass graft surgery involving the target lesion.
Measured: up to 18 months
Target vessel revascularization recorded at 6, 12 and 18 months
Measured: up to 18 months
Target limb revascularization recorded at 6, 12 and 18 months
Measured: up to 18 months
Improvement of clinical stage at 6, 12 and 18 months
Measured: up to 18 months
Change in ABI compared to pretreatment if vessels are compressible
Measured: up to 18 months
Hospitalization (extra days due to complications of the index procedure) and hospitalization between the follow-up visits due to the index leg
Measured: up to 18 months
Major amputations at the index limb
Measured: up to 18 months
Mortality
Measured: up to 18 months
LLL of stented segments at 6 months comparing the uncoated and the coated bal-loon group.
Measured: up to 18 months
Subgroup analysis; primary endpoint and TLR
Measured: up to 18 months
LLL, MLD and restenosis rate at 18 month follow-up determined by angiography
Measured: up to 18 months
Subgroup analysis neuropathy and no neuropathy according to clinical improve-ment in patients classified Rutherford 5
Measured: up to 18 months
Clinical benefit patients Rutherford 3 vs. Rutherford 4 and 5
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696956
- Sponsor's protocol ID
- Pac-3
- Other IDs
- Pac-3
- Acronym
- Piccolo
- Status last verified
- May 2008
- First submitted
- 10 Jun 2008
- Last updated
- 13 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Tepe 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 18272892Ma 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 42573020
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel Coated Balloons for Prevention of Restenosis in Small Arteries Below the Knee Compared to Angioplasty Using Uncoated Balloons
- ClinicalTrials.gov ID
- NCT00696956
- Acronym / sponsor ID
- Piccolo / Pac-3
- Conditions
- Atherosclerosis, Restenosis, Limb Ishemia
- Keywords
- local drug delivery, balloon angioplasty, safety and tolerance of paclitaxel coated PTA balloons, in inhibiting restenosis of below the knee arteries, Efficacy of paclitaxel coated PTA balloons, in inhibiting restenosis of below the knee arteries (late lumen loss)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 13 Jun 2008 (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 study will be performed as a randomized, double blind trial (in respect of the primary end point) with treatment of the stenotic lesion using uncoated PTA-catheters as control group. 114 patients will be included in the trial at about 5 study centers. Follow-up includes control angiography after 6 and 18 months and clinical follow-up examinations up to 18 months. Primary objective:
Efficacy of paclitaxel coated PTA balloons in inhibiting restenosis of below the knee arteries (late lumen loss)
Secondary objective:
Various angiographic and clinical efficacy measures, safety and tolerance of pacli-taxel coated PTA balloons in inhibiting restenosis of below the knee arteries Descriptive statistics, comparison by t-test, chi-square test for binary events 10.1 Descriptive statistics As far as applicable descriptive statistics will be applied to data and will be referring to individual changes versus baseline (predilatation or immediately postdilatation). The groups will be compared to each other testing the statistical significance of differences (p ≤ 0.05). Con-tinuous data will be expressed as mean ± standard deviation.
Categorical variables will be compared using the chi-squared test, and continuous variables will be compared using Student's t test or ANOVA analysis.
In addition to the assessment of the primary endpoint and the secondary endpoints a multi-variate analysis to investigate the influence of risk factors on the interventional outcome (interventional success, early restenosis/occlusion, LLL, stent integrity) and clinical outcomes will be performed. For this analysis the following factors will be considered: age, diabetes, neurological status (only Rutherford 5), lesion length, grade of dissection and calcification, reststenosis, number of run-off vessels, stent administration in the index lesion(s).
10.2 Estimated number of patients The primary endpoint of the study is late lumen loss (LLL) at 6 months evaluated by quantitative angiography. Because no data according this endpoint are available for both the control group and the group which will be treated with the paclitaxel coated balloon an assumption according the LLL at 6 months was made according the expectations of the principle investigator. An estimate for LLL as % of MLD in the control group is 50% and in the drug coated balloon group 30 %. The standard deviation is calculated to be 30% of LLL. A sample size of 37 patients in each group will allow the detection of a statistically significant difference (p<0.05) with 80% power. Based on the "Below study" which enrolled patients with comparable arterial lesions in Tuebingen and the data of the Basil study, it is estimated that 35% of the patients who will be enrolled in the study will not be available for follow-up investigations in order to calculate the MLD.
In order to meet a statistical endpoint a total of 114 patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Device: Balloon angioplasty (uncoated conventional balloon)Normal balloon for balloon angioplasty (Submarine, Ampherion Deep by Invatec) |
| 2 | Active comparator | Device: Balloon angioplasty (conventional but coated with 3 µg/mm2 paclitaxel)Paclitaxel coated balloon (same balloon like in the control group, but coated with 3 µg/mm2 Paclitaxel) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 95 years,
- peripheral vascular disease, Rutherford stage 3-5, diameter stenosis ≥ 70 %, ≥ 15 -150 mm length, up to 2 vessels to be treated
Key exclusion criteria (3 listed)
- Disease associated with life-expectancy less than 18 months
- Acute thrombus or aneurysm in the index limb/ vessel
- Doubts in the willingness or capability of the patient to allow follow up examination
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 (uncoated conventional balloon)endovascular therapy | Device | A |
| Balloon angioplasty (conventional but coated with 3 µg/mm2 paclitaxel)endovascular therapy | Device | 2 |
Primary outcome
Primary endpoint: Late lumen loss (LLL) of the target lesion after 6 months (assessed by DSA)
Time frame: after 6 months
16 secondary outcomes
Interventional success rate (defined as reststenosis less than 50%)
Time frame: up to 18 months
Restenosis rate at 6 and 18 months (restenosis rate is defined as a diameter stenosis of ≥ 50% of reference diameter
Time frame: up to 18 months
Minimum lumen diameter (MLD) at 6 months
Time frame: up to 18 months
Target lesion revascularization recorded at 6, 12 and 18 months; target lesion revascularization is defined as any reintervention or artery bypass graft surgery involving the target lesion.
Time frame: up to 18 months
Target vessel revascularization recorded at 6, 12 and 18 months
Time frame: up to 18 months
Target limb revascularization recorded at 6, 12 and 18 months
Time frame: up to 18 months
Improvement of clinical stage at 6, 12 and 18 months
Time frame: up to 18 months
Change in ABI compared to pretreatment if vessels are compressible
Time frame: up to 18 months
Hospitalization (extra days due to complications of the index procedure) and hospitalization between the follow-up visits due to the index leg
Time frame: up to 18 months
Major amputations at the index limb
Time frame: up to 18 months
Mortality
Time frame: up to 18 months
LLL of stented segments at 6 months comparing the uncoated and the coated bal-loon group.
Time frame: up to 18 months
Subgroup analysis; primary endpoint and TLR
Time frame: up to 18 months
LLL, MLD and restenosis rate at 18 month follow-up determined by angiography
Time frame: up to 18 months
Subgroup analysis neuropathy and no neuropathy according to clinical improve-ment in patients classified Rutherford 5
Time frame: up to 18 months
Clinical benefit patients Rutherford 3 vs. Rutherford 4 and 5
Time frame: up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2008.
- Background: 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.
- 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.
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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.
5 sites 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 (uncoated conventional balloon) and Balloon angioplasty (conventional but coated with 3 µg/mm2 paclitaxel) in people with Atherosclerosis and Restenosis, run by University Hospital Tuebingen at 5 sites 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 2 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 13 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. 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?
Contact Gunnar Tepe, MD (49-707-129 ext. 83371, 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?
Primary endpoint: Late lumen loss (LLL) of the target lesion after 6 months (assessed by DSA) (time frame: 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 NCT00696956, which also lists 2 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 13 Jun 2008.