Peripheral Arterial DiseasePhase 1/2PACCOCATH_FNCT00472472
Paclitaxel Coated Balloon Catheter for Prevention of Restenosis in Femoropopliteal Arteries
A Phase 1/2 study testing paclitaxel coated balloon catheter (device with drug) in people with Peripheral Arterial Disease, run by University Hospital, Saarland at 2 sites in Germany.
Trial summary
The PACCOCATH FEM study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis after femoropopliteal angioplasty. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- paclitaxel coated balloon catheter (device with drug)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2004to Jul 2007
- Phase
- Phase 1/2
- 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
- Rutherford stage 1, 2, 3, 4 oder 5
- Occlusion or Stenosis of Superficial femoral and/or popliteal artery
- Successful guide wire passage of the lesion
- Patient suitable of vascular surgery in case of complication
- Written consent
- Patient is willing to take part in follow up examinations within the study
Who cannot join
- Acute ischemia
- Distal run off less than one vessel
- Pregnancy
- Hyperthyroidism
- Thrombocytes <100.000/mm3 or >700.000/mm3, Leucocytes <3.000/mm3
- Life expectancy less than two years
- Patients not willing to enter the study
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Klinik für Strahlenheilkunde, Charité Campus Virchow Klinikum
Berlin, 13353
Institut für Diagnostische Radiologie und Neuroradiologie, Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität
Greifswald, 17487
About this study
Official title: Paclitaxel Coated Balloon Catheter for Inhibition of Restenosis in Femoropopliteal Arteries (PACCOCATH - FEM I)
The PACCOCATH FEM study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis after femoropopliteal angioplasty.
Read the detailed description
Background: Treatment of patients with peripheral arterial disease (PAD) in the femoropopliteal arteries by percutaneous intervention is still limited by high rates of restenosis. The aim of the present study is to evaluate the efficacy and safety of a novel method of short time local drug delivery based on a paclitaxel-coated balloon in femoropopliteal arteries.
Methods and results: The double-blind and randomized study enrolled n=79 patients with occlusion or stenosis of femoropopliteal arteries. Inclusion criteria were clinical Rutherford stage 1-5, occlusion or hemodynamic relevant stenosis (≥ 70 % diameter) of femoropopliteal arteries and successful guiding wire recanalization. The primary endpoint was the late lumen loss after 6 months follow-up as seen in angiography. Secondary endpoints included the rate of restenosis (a binary variable), change of ankle brachial index (ABI), rutherford class and major adverse events.
- Conditions
- Peripheral Arterial Disease
- Being tested
- paclitaxel coated balloon catheter (device with drug)
- Keywords
- restenosis, peripheral arterial disease, paccocath, drug-coated balloon
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel coated balloon catheter (device with drug)Device
PTA vs Paccocath
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | PTA Receives: Device: paclitaxel coated balloon catheter (device with drug) |
| 2 | Active comparator | PTA with Paccocath Receives: Device: paclitaxel coated balloon catheter (device with drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
angiographic late lumen loss
Measured: 6 months
Secondary outcomes (1)
binary restenosis rate; major adverse events
Measured: 18 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 2007 (estimated)
- Study startApr 2004
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Investigators
- Jens Ricke, MD, Principal investigator, Klinik für Strahlenheilkunde, Charité Campus Virchow, Augustenburger Platz 1, 13353 Berlin, GermanyUlrich Speck, PhD, Study director, Radiologie, Campus Mitte, Charite, 10117 Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472472
- Sponsor's protocol ID
- PACCOCATH - FEM I
- Acronym
- PACCOCATH_F
- Status last verified
- May 2007
- First submitted
- 10 May 2007
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. doi: 10.1161/01.CIR.0000138929.71660.E0. Epub 2004 Aug 9.
PubMed 15302790Speck U, Scheller B, Abramjuk C, Grossmann S, Mahnkopf D, Simon O. Inhibition of restenosis in stented porcine coronary arteries: uptake of Paclitaxel from angiographic contrast media. Invest Radiol. 2004 Mar;39(3):182-6. doi: 10.1097/01.rli.0000116125.96544.64.
PubMed 15076010Scheller B, Speck U, Schmitt A, Bohm M, Nickenig G. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol. 2003 Oct 15;42(8):1415-20. doi: 10.1016/s0735-1097(03)01056-8.
PubMed 14563585Scheller B, Speck U, Romeike B, Schmitt A, Sovak M, Bohm M, Stoll HP. Contrast media as carriers for local drug delivery. Successful inhibition of neointimal proliferation in the porcine coronary stent model. Eur Heart J. 2003 Aug;24(15):1462-7. doi: 10.1016/s0195-668x(03)00317-8.
PubMed 12909076Scheller B, Speck U, Bohm M. Prevention of restenosis: is angioplasty the answer? Heart. 2007 May;93(5):539-41. doi: 10.1136/hrt.2007.118059.
PubMed 17435062Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.
PubMed 17101615Speck U, Scheller B, Abramjuk C, Breitwieser C, Dobberstein J, Boehm M, Hamm B. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology. 2006 Aug;240(2):411-8. doi: 10.1148/radiol.2402051248.
PubMed 16864669Ma 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 42573020Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8.
PubMed 18779447
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel Coated Balloon Catheter for Inhibition of Restenosis in Femoropopliteal Arteries (PACCOCATH - FEM I)
- ClinicalTrials.gov ID
- NCT00472472
- Acronym / sponsor ID
- PACCOCATH_F / PACCOCATH - FEM I
- Conditions
- Peripheral Arterial Disease
- Keywords
- restenosis, peripheral arterial disease, paccocath, drug-coated balloon
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 11 May 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.
The PACCOCATH FEM study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis after femoropopliteal angioplasty.
Detailed description
Background: Treatment of patients with peripheral arterial disease (PAD) in the femoropopliteal arteries by percutaneous intervention is still limited by high rates of restenosis. The aim of the present study is to evaluate the efficacy and safety of a novel method of short time local drug delivery based on a paclitaxel-coated balloon in femoropopliteal arteries.
Methods and results: The double-blind and randomized study enrolled n=79 patients with occlusion or stenosis of femoropopliteal arteries. Inclusion criteria were clinical Rutherford stage 1-5, occlusion or hemodynamic relevant stenosis (≥ 70 % diameter) of femoropopliteal arteries and successful guiding wire recanalization. The primary endpoint was the late lumen loss after 6 months follow-up as seen in angiography. Secondary endpoints included the rate of restenosis (a binary variable), change of ankle brachial index (ABI), rutherford class and major adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Device: paclitaxel coated balloon catheter (device with drug)PTA |
| 2 | Active comparator | Device: paclitaxel coated balloon catheter (device with drug)PTA with Paccocath |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Rutherford stage 1, 2, 3, 4 oder 5
- Occlusion or Stenosis of Superficial femoral and/or popliteal artery
- Successful guide wire passage of the lesion
- Patient suitable of vascular surgery in case of complication
- Written consent
Key exclusion criteria (7 listed)
- Acute ischemia
- Distal run off less than one vessel
- Pregnancy
- Hyperthyroidism
- Thrombocytes <100.000/mm3 or >700.000/mm3, Leucocytes <3.000/mm3
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 |
|---|---|---|
| paclitaxel coated balloon catheter (device with drug)PTA vs Paccocath | Device | 1, 2 |
Primary outcome
angiographic late lumen loss
Time frame: 6 months
1 secondary outcome
binary restenosis rate; major adverse events
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2010.
- Background: PubMed 15302790Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. doi: 10.1161/01.CIR.0000138929.71660.E0. Epub 2004 Aug 9.
- Background: PubMed 15076010Speck U, Scheller B, Abramjuk C, Grossmann S, Mahnkopf D, Simon O. Inhibition of restenosis in stented porcine coronary arteries: uptake of Paclitaxel from angiographic contrast media. Invest Radiol. 2004 Mar;39(3):182-6. doi: 10.1097/01.rli.0000116125.96544.64.
- Background: PubMed 14563585Scheller B, Speck U, Schmitt A, Bohm M, Nickenig G. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol. 2003 Oct 15;42(8):1415-20. doi: 10.1016/s0735-1097(03)01056-8.
- Background: PubMed 12909076Scheller B, Speck U, Romeike B, Schmitt A, Sovak M, Bohm M, Stoll HP. Contrast media as carriers for local drug delivery. Successful inhibition of neointimal proliferation in the porcine coronary stent model. Eur Heart J. 2003 Aug;24(15):1462-7. doi: 10.1016/s0195-668x(03)00317-8.
- Background: PubMed 17435062Scheller B, Speck U, Bohm M. Prevention of restenosis: is angioplasty the answer? Heart. 2007 May;93(5):539-41. doi: 10.1136/hrt.2007.118059.
- Background: PubMed 17101615Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.
- Background: PubMed 16864669Speck U, Scheller B, Abramjuk C, Breitwieser C, Dobberstein J, Boehm M, Hamm B. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology. 2006 Aug;240(2):411-8. doi: 10.1148/radiol.2402051248.
- 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 18779447Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8.
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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.
Jens Ricke, MD principal investigator
Klinik für Strahlenheilkunde, Charité Campus Virchow, Augustenburger Platz 1, 13353 Berlin, Germany
Ulrich Speck, PhD study director
Radiologie, Campus Mitte, Charite, 10117 Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing paclitaxel coated balloon catheter (device with drug) in people with Peripheral Arterial Disease, run by University Hospital, Saarland at 2 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 30 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
angiographic late lumen loss (time frame: 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 NCT00472472, which also lists 9 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 30 Jun 2010.