IschemiaPEPCAD VNCT00540813
Paclitaxel-Eluting Balloon Angioplasty and Coroflex™-Stents in the Treatment of Bifurcated Coronary Lesions
A study testing drug eluting balloon in people with Ischemia and Stenosis, run by Heart Centre Rotenburg at 2 sites in Germany.
Trial summary
The aim of the study is to investigate the feasibility of Paclitaxel-eluting PTCA-balloon dilation (SeQuent Please) followed by bare metal stent (Coroflex ) deployment in the main branch (reference diameter: ≥ 2.5 mm and ≤ 3.8 mm, reference diameter of side branch: ≥ 2.0 mm and ≤ 3.5 mm, length of stenoses in either… Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 28 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2007to Oct 2016
- 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
- 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
- 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-month 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 9-month angiographic follow-up
- Patients must agree to undergo the 3-year clinical follow-up
- Patient is able to verbally acknowledge and understand the associated risks, benefits, and treatment alternatives of this trial. The patients, by providing their informed consent, must agree to these risks and benefits as stated in the patient informed consent document.
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- De-novo bifurcational native left coronary artery lesion (reference diameter LAD or LCx: 2.5 mm to 3.8 mm, length of stenosis: ≤ 20 mm, reference diameter D1/D2 or OMS1/OMS2: 2.0 mm to 3.5 mm, length of stenosis: ≤ 20 mm)
- Diameter stenosis pre procedure must be either more then 70 % in either one or both branches of the lesion (i.e., bifurcational lesion of any type of the Medina classification) or more then 50 % if ischemia corresponding to the target lesion is documented either by exercise stress ECG, stress echocardiography, scintigraphy, MRT, or suspected based on angina pectoris
- Single or multi-vessel coronary artery disease
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 mmHg requiring inotropic support, IABP, and/or fluid challenge)
- Patients with severe valvular heart disease
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- Women who are pregnant or lactating
- Patients with life expectancy of less than five years or factors making clinical follow-up difficult
- Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
- Patients who had a cerebral stroke < 6 months prior to the procedure
- 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, "Cockcroft Gault") and is therefore at high risk for angiography associated renal complications. 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., malignancy)
- Addiction to any drug or to alcohol
- Patients with any type of surgery during the week preceding the interventional procedure.
- Therapy with anticoagulants
- Evidence of extensive thrombosis within target vessel before the intervention
- Multilesion percutaneous coronary intervention beside the bifurcation lesion in the left coronary artery (no other intervention is admitted during the same procedure)
- Patients with another coronary stent implanted previously into the target vessel ≤ 15 mm distant to the current lesion, drug eluting stents less than 9 months and bare metal stents or stents with passive coatings less than 3 months before the PEPCAD V BIF
- Target lesion located in any type of coronary bypass (i.e., venous graft, arterial bypass) or graft/native artery connection
- Coronary artery occlusion of any type (e.g., acute or chronic)
- In-stent restenosis
- In-segment restenosis of the native vessel within 4 mm adjacent to the target lesion
Trial locations and contacts
2 sites in 1 country.
About this study
The aim of the study is to investigate the feasibility of Paclitaxel-eluting PTCA-balloon dilation (SeQuent Please) followed by bare metal stent (Coroflex ) deployment in the main branch (reference diameter: ≥ 2.5 mm and ≤ 3.8 mm, reference diameter of side branch: ≥ 2.0 mm and ≤ 3.5 mm, length of stenoses in either branch ≤ 20 mm) in the treatment of significant (>70%) de-novo-bifurcation stenoses of any Medina classification type in the native left coronary artery as reflected by procedural success and to evaluate the preservation of vessel patency.
- Being tested
- drug eluting balloon
- Keywords
- bifurcation stenosis, Patients with documented ischemia due to a de-novo bifurcation stenosis
- Medical subject headings
- Ischemia, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug eluting balloonDevice
drug eluting balloon bifurcated coronary lesions single arm study
| Study group | Role | What they receive |
|---|---|---|
| Drug Eluting Balloon | Experimental | Not described Receives: Device: drug eluting balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success (main branch ≤ 30%, side branch ≤ 50%, TIMI Flow 3)
Measured: acute
Secondary outcomes (1)
In-segment late lumen loss at 9 months in either branch
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionMay 2011
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Centre Rotenburg
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Melsungen AG, Clinical Research Institute Rotenburg a.d.F.
- Responsible party
- Principal investigator, Ralf Degenhardt, PhD, Heart Centre Rotenburg
- Investigators
- D. G. Mathey, MD, Principal investigator, Hamburg University Cardiovascular Center GmbHF. X. Kleber, MD, Principal investigator, Department of Internal Medicine Unfallkrankenhaus Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540813
- Sponsor's protocol ID
- BBM-VS-56
- Acronym
- PEPCAD V
- Status last verified
- Feb 2017
- First submitted
- 5 Oct 2007
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel-Eluting Balloon Angioplasty and Coroflex™-Stents in the Treatment of Bifurcated Coronary Lesions
- ClinicalTrials.gov ID
- NCT00540813
- Acronym / sponsor ID
- PEPCAD V / BBM-VS-56
- Keywords
- bifurcation stenosis, Patients with documented ischemia due to a de-novo bifurcation stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Heart Centre RotenburgUniversity, hospital or other
- Collaborators
- B. Braun Melsungen AG, Clinical Research Institute Rotenburg a.d.F.
- Study start
- Oct 2007
- Primary completion
- May 2011 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 8 Oct 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 aim of the study is to investigate the feasibility of Paclitaxel-eluting PTCA-balloon dilation (SeQuent Please) followed by bare metal stent (Coroflex ) deployment in the main branch (reference diameter: ≥ 2.5 mm and ≤ 3.8 mm, reference diameter of side branch: ≥ 2.0 mm and ≤ 3.5 mm, length of stenoses in either branch ≤ 20 mm) in the treatment of significant (>70%) de-novo-bifurcation stenoses of any Medina classification type in the native left coronary artery as reflected by procedural success and to evaluate the preservation of vessel patency.
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 balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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
- 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-month 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 9-month angiographic follow-up
- Patients must agree to undergo the 3-year clinical follow-up
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 mmHg 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 balloondrug eluting balloon bifurcated coronary lesions single arm study | Device | Drug Eluting Balloon |
Primary outcome
Procedural success (main branch ≤ 30%, side branch ≤ 50%, TIMI Flow 3)
Time frame: acute
1 secondary outcome
In-segment late lumen loss at 9 months in either branch
Time frame: 9 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 23 Feb 2017.
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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.
D. G. Mathey, MD principal investigator
Hamburg University Cardiovascular Center GmbH
F. X. Kleber, MD principal investigator
Department of Internal Medicine Unfallkrankenhaus Berlin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drug eluting balloon in people with Ischemia and Stenosis, run by Heart Centre Rotenburg 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 9 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 23 Feb 2017. 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. 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?
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?
Procedural success (main branch ≤ 30%, side branch ≤ 50%, TIMI Flow 3) (time frame: acute). 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 23 Feb 2017.