Coronary StenosisPhase 2NCT00404144
PEPCAD I. The Paclitaxel-Eluting PTCA-Balloon Catheter to Treat Small Vessel
A Phase 2 study testing Drug Eluting Balloon in people with Coronary Stenosis, run by Heart Centre Rotenburg at 9 sites in Germany.
Trial summary
The objective of this study is to assess the safety and efficacy of the Paclitaxel-eluting PTCA-balloon catheter (3µg/mm2 balloon surface area) in the treatment of significant (≥ 70% and < 100 %) stenoses in native coronary arteries with reference diameters from 2.25 mm to 2.8 mm and ≤ 22 mm in length for procedural… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis
- What is being tested?
- Drug Eluting Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 9 sitesGermany
- Study dates
- Jan 2006to Sep 2012
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable angina pectoris (CCS class 1-3) or with unstable angina pectoris (Braunwald class 1-2, A-C) or documented ischemia or with documented silent ischemia
- Patients eligible for coronary revascularization by means of PCI
- Patients suitable for coronary revascularization of any sort (balloon angioplasty, device-assisted balloon-angioplasty or coronary artery bypass grafting)
- Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the first year following the study procedure. Hence, patients will be advised to use an adequate birth control method up to and including 6 months follow-up.
- Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol
- Patients must agree to undergo the 6 months angiographic follow-up
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- Patients must agree to undergo the 1 and 3 year clinical follow-up
- Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g., balloon angioplasty by means of the Paclitaxel-eluting PTCA-balloon catheter. The patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document
- Patients with medical indication for follow-up angiography
- Reference diameters from 2.25 mm to 2.8 mm and ≤ 22 mm in length
- Diameter stenosis pre procedure must be either > 70 % or >50 % if ischemia corresponding to the target lesion is documented either by exercise stress ECG, stress echocardiography, or scintigraphy
- The target lesion must be covered by a single Paclitaxel-eluting balloon
Who cannot join
- Patients with acute (< 24 h) or recent (≤ 48 hours) myocardial infarction
- Patients with unstable angina pectoris (Braunwald class 3)
- Patients with severe congestive heart failure
- Patients with severe heart failure NYHA IV
- Patients demonstrating clinical signs of cardiogenic shock at the time of the procedure (systolic blood pressure of less than 80 mm Hg requiring inotropic support, IABP and/or fluid challenge).
- Women who are pregnant or lactating
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- Patients with another coronary stent implanted previously into the target vessel
- Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
- Patient participates in other clinical trials involving any investigational device or drug
- Untreated hyperthyroidism
- Patient has presence or history of severe renal failure (GFR<30ml/min) and is therefore not eligible for angiography. Patient's serum creatinine levels must be documented
- Post transplantation of any organ or immune suppressive medication
- Other disease to jeopardize follow-up (e.g., malignoma)
- Addiction to any drug or to alcohol
- Patients with any type of surgery during the week preceding the interventional procedure
- Evidence of extensive thrombosis within target vessel before the intervention
- Side branch > 2 mm in diameter originating from the lesion
- Bifurcate lesion
- Restenotic lesion
- Multilesion percutaneous coronary intervention within the same artery (a main artery (e.g., LCdx) and its side branch (e.g., OMS) are considered as different arteries)
- Percutaneous coronary intervention of venous graft
- Target segment is occluded (i.e., acute or chronic)
- In-stent restenosis
- Ostial lesion within 2 mm of vessel origin
- Patient is intolerant to aspirin and/or the ADP-antagonists clopidogrel or has a history of neutropenia, thrombocytopenia induced by ADP-antagonists, or severe hepatic dysfunction prohibiting the use of clopidogrel
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Kerckhoff-Clinic Bad Nauheim
Bad Nauheim, D-61231
Unfallkrankenhaus Berlin
Berlin, D-12683
Medizinische Klinik, Kardiologie, St.-Johannes -Hospital
Dortmund, D-44137
Städtische Kliniken Esslingen, Klinik für Kardiologie, Angiologie und Pneumologie
Esslingen am Neckar, D-73730
Martin-Luther-Universität Halle-Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin III
Halle, D-06097
University of Heidelberg, Clinic for Internal Medicine, Dept. of Cardiology
Heidelberg, D-69120
University of Saarland, Internal Medicine III
Homburg/Saar, D-66421
Universitätklinikum Jena, Klinik für Innere Medizin
Jena, D-07740
Center for Cardiovascular Diseases, Cardiologic Clinic
Rotenburg A.d. Fulda, D-36199
About this study
Official title: PEPCAD I, The Paclitaxel-Eluting PTCA-Balloon Catheter to Treat Small Vessel Coronary Artery Disease. A Pilot Study
The objective of this study is to assess the safety and efficacy of the Paclitaxel-eluting PTCA-balloon catheter (3µg/mm2 balloon surface area) in the treatment of significant (≥ 70% and < 100 %) stenoses in native coronary arteries with reference diameters from 2.25 mm to 2.8 mm and ≤ 22 mm in length for procedural success and preservation of vessel patency.
Read the detailed description
Background information:
Stent deployment for the treatment of coronary artery stenoses has evolved as the standard treatment in nearly all types of coronary lesions over the past two decades. The initial recurrence rate of bare stents in the range of 20 30 % in low risk stenoses has been further reduced by devices with passive coatings such as silicon carbide, heparin, phosphorylcholine, and carbon.
In the percutaneous transluminal treatment of stenotic coronary arteries with diameters below 3 mm, however, none of the currently available methods, namely balloon angioplasty with conventional balloons (POBA) and deployment of non-drug eluting stents have shown acceptable results for the various reasons inherent to these approaches. Although some studies showed POBA and the deployment of bare stents to be equally effective with respect to restenosis, in a recently published meta-analysis of eleven trials the restenosis rates were as high as 25.8 % for POBA and 34.2 % for bare stents, respectively.
Brachytherapy initially demonstrated encouraging results. However, due to its disadvantages such as delayed endothelialization, the risk associated with additional stenting, the cumbersome logistics at the sites and in the labs, brachytherapy is not considered as a valid approach. Data with the Sirolimus-eluting Cypher™ stent in vessels averaging 2.60 ± 0.54 mm in diameter showed the benefit of this cytostatic drug in this indication. However, this approach introduces a layer of metal to the per se small vessel and, thus, reduces the vascular lumen.
Study Rationale:
Since none of the above mentioned options for the percutaneous treatment of small vessel coronary artery stenoses seems to be universally recommendable the Paclitaxel-eluting PTCA balloon catheter has to be considered as an alternative. The possible advantages over either the uncoated balloon or bare stent include the antiproliferative mode of action of the compound. In comparison to the drug eluting stents (DES) the homogenous distribution of the compound along the target vessel segment, the lack of chronic mechanical alteration of the artery and the ease of access to the lesion would favor the Paclitaxel-eluting balloon.
However, there are no data available on the use of the drug eluting balloons in small vessel disease and the information on the other indication evaluated to date, the treatment of in-stent restenosis is limited. In the latter indication, the animal model and according to unpublished results in humans, the proliferation induced by a Paclitaxel-eluting balloon catheter was significantly less compared to an uncoated balloon, the Paclitaxel-coated Taxus™ stent, and to the Sirolimus-eluting Cypher™ stent. Therefore, it is prudent to test the Paclitaxel-eluting PTCA balloon catheter as an alternative approach for the percutaneous transluminal treatment of small vessel coronary artery lesions.
Since none of the alternative methods has unequivocally shown its superiority over the other, none of them may serve as the golden standard and, i.e., for direct comparison. Consequently, as the initial step conducting a single arm study with the Paclitaxel-eluting balloon is suggested with historic data serving for comparison. Once these results will have been obtained a prospective randomized trial shall be discussed.
- Conditions
- Coronary Stenosis
- Being tested
- Drug Eluting Balloon
- Keywords
- small vessel, paclitaxel coated balloon catheter, pepcad, drug eluting balloon
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Eluting BalloonDevice
PCI of small vessels single arm study
| Study group | Role | What they receive |
|---|---|---|
| Drug Eluting Balloon | Experimental | treatment of small vessel with drug eluting balloon Receives: Device: Drug Eluting Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late lumen loss at 6 months
Measured: 6 month
Secondary outcomes (8)
Procedural success
Measured: during procedure
30-day MACE rate
Measured: 30 days
Percent stenosis at 6 months
Measured: 6 months
Binary restenosis rate at 6 months
Measured: 6 months
Late loss index at 6 months
Measured: 6 months
Cumulative MACE rate at 6 months
Measured: 6 months
Cumulative MACE rate at 1 year
Measured: 1 year
Cumulative MACE rate at 3 years
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startJan 2006
- Primary completionAug 2010
- Study completionSep 2012
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 Coronary 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Centre Rotenburg
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Melsungen AG, Clinical Research Institute, Center for Cardiovascular Disease Rotenburg a.d.F.
- Responsible party
- Principal investigator, Ralf Degenhardt, PhD, Heart Centre Rotenburg
- Investigators
- M. Unverdorben, MD,PhD, Principal investigator, Center for Cardiovascular Diseases, Heinz-Meise-Strasse 100, D-36199 Rotenburg a.d. Fulda, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404144
- Sponsor's protocol ID
- ID: BBM-VS-52
- Other IDs
- PEPCAD II/CRI/05/-01/c-c
- Status last verified
- Mar 2015
- First submitted
- 24 Nov 2006
- Last updated
- 19 Mar 2015
- Results posted
- No
Publications
Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter in the PEPCAD I study: are lesions clinically stable from 12 to 36 months? EuroIntervention. 2013 Sep;9(5):620-8. doi: 10.4244/EIJV9I5A99.
PubMed 24058078Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2010 Mar;99(3):165-74. doi: 10.1007/s00392-009-0101-6. Epub 2010 Jan 6.
PubMed 20052480
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEPCAD I, The Paclitaxel-Eluting PTCA-Balloon Catheter to Treat Small Vessel Coronary Artery Disease. A Pilot Study
- ClinicalTrials.gov ID
- NCT00404144
- Acronym / sponsor ID
- ID: BBM-VS-52
- Conditions
- Coronary Stenosis
- Keywords
- small vessel, paclitaxel coated balloon catheter, pepcad, drug eluting balloon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Heart Centre RotenburgUniversity, hospital or other
- Collaborators
- B. Braun Melsungen AG, Clinical Research Institute, Center for Cardiovascular Disease Rotenburg a.d.F.
- Study start
- Jan 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 27 Nov 2006 (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 objective of this study is to assess the safety and efficacy of the Paclitaxel-eluting PTCA-balloon catheter (3µg/mm2 balloon surface area) in the treatment of significant (≥ 70% and < 100 %) stenoses in native coronary arteries with reference diameters from 2.25 mm to 2.8 mm and ≤ 22 mm in length for procedural success and preservation of vessel patency.
Detailed description
Background information:
Stent deployment for the treatment of coronary artery stenoses has evolved as the standard treatment in nearly all types of coronary lesions over the past two decades. The initial recurrence rate of bare stents in the range of 20 30 % in low risk stenoses has been further reduced by devices with passive coatings such as silicon carbide, heparin, phosphorylcholine, and carbon.
In the percutaneous transluminal treatment of stenotic coronary arteries with diameters below 3 mm, however, none of the currently available methods, namely balloon angioplasty with conventional balloons (POBA) and deployment of non-drug eluting stents have shown acceptable results for the various reasons inherent to these approaches. Although some studies showed POBA and the deployment of bare stents to be equally effective with respect to restenosis, in a recently published meta-analysis of eleven trials the restenosis rates were as high as 25.8 % for POBA and 34.2 % for bare stents, respectively.
Brachytherapy initially demonstrated encouraging results. However, due to its disadvantages such as delayed endothelialization, the risk associated with additional stenting, the cumbersome logistics at the sites and in the labs, brachytherapy is not considered as a valid approach. Data with the Sirolimus-eluting Cypher™ stent in vessels averaging 2.60 ± 0.54 mm in diameter showed the benefit of this cytostatic drug in this indication. However, this approach introduces a layer of metal to the per se small vessel and, thus, reduces the vascular lumen.
Study Rationale:
Since none of the above mentioned options for the percutaneous treatment of small vessel coronary artery stenoses seems to be universally recommendable the Paclitaxel-eluting PTCA balloon catheter has to be considered as an alternative. The possible advantages over either the uncoated balloon or bare stent include the antiproliferative mode of action of the compound. In comparison to the drug eluting stents (DES) the homogenous distribution of the compound along the target vessel segment, the lack of chronic mechanical alteration of the artery and the ease of access to the lesion would favor the Paclitaxel-eluting balloon.
However, there are no data available on the use of the drug eluting balloons in small vessel disease and the information on the other indication evaluated to date, the treatment of in-stent restenosis is limited. In the latter indication, the animal model and according to unpublished results in humans, the proliferation induced by a Paclitaxel-eluting balloon catheter was significantly less compared to an uncoated balloon, the Paclitaxel-coated Taxus™ stent, and to the Sirolimus-eluting Cypher™ stent. Therefore, it is prudent to test the Paclitaxel-eluting PTCA balloon catheter as an alternative approach for the percutaneous transluminal treatment of small vessel coronary artery lesions.
Since none of the alternative methods has unequivocally shown its superiority over the other, none of them may serve as the golden standard and, i.e., for direct comparison. Consequently, as the initial step conducting a single arm study with the Paclitaxel-eluting balloon is suggested with historic data serving for comparison. Once these results will have been obtained a prospective randomized trial shall be discussed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug Eluting Balloon | Experimental | Device: Drug Eluting Balloontreatment of small vessel with drug eluting balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with stable angina pectoris (CCS class 1-3) or with unstable angina pectoris (Braunwald class 1-2, A-C) or documented ischemia or with documented silent ischemia
- Patients eligible for coronary revascularization by means of PCI
- Patients suitable for coronary revascularization of any sort (balloon angioplasty, device-assisted balloon-angioplasty or coronary artery bypass grafting)
- Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the first year following the study procedure. Hence, patients will be advised to use an adequate birth control method up to and including 6 months follow-up.
- Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol
Key exclusion criteria (25 listed)
- Patients with acute (< 24 h) or recent (≤ 48 hours) myocardial infarction
- Patients with unstable angina pectoris (Braunwald class 3)
- Patients with severe congestive heart failure
- Patients with severe heart failure NYHA IV
- Patients demonstrating clinical signs of cardiogenic shock at the time of the procedure (systolic blood pressure of less than 80 mm Hg requiring inotropic support, IABP and/or fluid challenge).
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 |
|---|---|---|
| Drug Eluting BalloonPCI of small vessels single arm study | Device | Drug Eluting Balloon |
Primary outcome
Late lumen loss at 6 months
Time frame: 6 month
8 secondary outcomes
Procedural success
Time frame: during procedure
30-day MACE rate
Time frame: 30 days
Percent stenosis at 6 months
Time frame: 6 months
Binary restenosis rate at 6 months
Time frame: 6 months
Late loss index at 6 months
Time frame: 6 months
Cumulative MACE rate at 6 months
Time frame: 6 months
Cumulative MACE rate at 1 year
Time frame: 1 year
Cumulative MACE rate at 3 years
Time frame: 3 years
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 19 Mar 2015.
- Derived from this study: PubMed 24058078Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter in the PEPCAD I study: are lesions clinically stable from 12 to 36 months? EuroIntervention. 2013 Sep;9(5):620-8. doi: 10.4244/EIJV9I5A99.
- Derived from this study: PubMed 20052480Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2010 Mar;99(3):165-74. doi: 10.1007/s00392-009-0101-6. Epub 2010 Jan 6.
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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.
M. Unverdorben, MD,PhD principal investigator
Center for Cardiovascular Diseases, Heinz-Meise-Strasse 100, D-36199 Rotenburg a.d. Fulda, Germany
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug Eluting Balloon in people with Coronary Stenosis, run by Heart Centre Rotenburg at 9 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 12 inclusion and 25 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 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. 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 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?
Late lumen loss at 6 months (time frame: 6 month). 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 NCT00404144, 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 19 Mar 2015.