Coronary De-novo StenosesPhase 3PEPCAD-DEBonlyNCT01084408
Efficacy of the SeQuent®Please in the Treatment of De-novo Stenoses Versus Taxus™Liberté™
A Phase 3 study testing SeQuent®Please (Paclitaxel coated balloon) and Taxus™Liberté™ (Paclitaxel eluting stent) in people with Coronary De-novo Stenoses, run by University Hospital, Saarland at 2 sites in Germany.
Trial summary
The aim of the trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a drug eluting stent. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary De-novo Stenoses
- What is being tested?
- SeQuent®Please (Paclitaxel coated balloon) and Taxus™Liberté™ (Paclitaxel eluting stent)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Mar 2010to 1 Mar 2013
- Phase
- Phase 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Clinical evidence of stable or unstable angina or a positive functional study
- Single, stenotic de novo lesion in a native coronary artery, type A or selected B1 (see 4.3.1.1 Definition of lesion types)
- Diameter stenosis > 70% (visual estimate)
- Vessel diameter 2.5 - 3.5 mm
- Female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization
- Signed patient informed consent form
- Patient's and treating physician's agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol
Who cannot join
- Left ventricular ejection fraction of < 30%
- Visible thrombus proximal to the lesion
- Expection that treatment with devices other than PTCA will be required for this lesion.
- Stenosis is within a bypass graft
- Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated
- Other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy, cause the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years).
Show all 12Show fewer
- Acute myocardial infarction within the past 72 hours of the intended treatment (de-fined as: Q wave infarction having total creatinine kinase (CK) >3 times the upper normal limit, or CK remains elevated above hospital normal at time of treatment)
- Chronic renal insufficiency with serum creatinine > 2.0 mg%
- Significant gastrointestinal (GI) bleed within the past six months.
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions
- Extensive peripheral vascular disease that precludes safe 6 French sheath insertion and / or requires additional anti-platelet and / or anti-coagulation treatment.
- Participating in another device or drug study within the last 6 months which may inter-fere with the interpretation of results of this study
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Medizinisches Versorgungszentrum
Hamburg, 22527
Klinik für Kardiologie, Angiologie und Konservative Intensivtherapie Klinikum Ernst von Bergmann
Postdam, Brandenburg, 14467
About this study
Official title: Randomized Trial on the Treatment of Coronary De-novo Lesions With a Drug Eluting Stent or a Drug Coated Balloon
The aim of the trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a drug eluting stent.
- Conditions
- Coronary De-novo Stenoses
- Being tested
- SeQuent®Please (Paclitaxel coated balloon), Taxus™Liberté™ (Paclitaxel eluting stent)
- Keywords
- de-novo, coronary stenoses, PEPCAD, DEBonly, Paclitaxel
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeQuent®Please (Paclitaxel coated balloon)Device
PCI of de-novo lesions
Taxus™Liberté™ (Paclitaxel eluting stent)Device
PCI of de-novo lesions
| Study group | Role | What they receive |
|---|---|---|
| Sequent®Please | Active comparator | Not described Receives: Device: SeQuent®Please (Paclitaxel coated balloon) |
| Taxus™Liberté™ | Active comparator | Not described Receives: Device: Taxus™Liberté™ (Paclitaxel eluting stent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late lumen loss
Late lumen loss = MLD in-lesion initially - MLD in lesion after six months (after nitroglycerin in identical projections); assessment by an independent Core Lab.
Measured: 6 months
Secondary outcomes (5)
Thrombotic occlusion of the target lesion
Measured: 30 days, 6, 12, 24, 60 months
Revascularization of the target lesion
Measured: 30 days, 6, 12, 24, 60 months
Myocardial infarction
Measured: 30 days, 6, 12, 24, 60 months
Death
Measured: 30 days, 6, 12, 24, 60 months
Combined clinical endpoint (MACE)
consisting of thrombotic occlusion of the treated segment, target lesion revascularization, myocardial infarction, or death
Measured: 30 days, 6, 12, 24, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study start1 Mar 2010
- Primary completion1 Mar 2012
- Study completion1 Mar 2013
Why it stopped: no suitable patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary De-novo StenosesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Scheller, University Hospital, Saarland
- Investigators
- Bruno Scheller, Prof. Dr. med, Principal investigator, Uniklinikum des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084408
- Sponsor's protocol ID
- Pac 14
- Acronym
- PEPCAD-DEBonly
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2010
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial on the Treatment of Coronary De-novo Lesions With a Drug Eluting Stent or a Drug Coated Balloon
- ClinicalTrials.gov ID
- NCT01084408
- Acronym / sponsor ID
- PEPCAD-DEBonly / Pac 14
- Conditions
- Coronary De-novo Stenoses
- Keywords
- de-novo, coronary stenoses, PEPCAD, DEBonly, Paclitaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no suitable patients
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- 1 Mar 2010 (actual)
- Primary completion
- 1 Mar 2012 (actual)
- Study completion
- 1 Mar 2013 (actual)
- First posted
- 10 Mar 2010 (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 trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a drug eluting stent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequent®Please | Active comparator | Device: SeQuent®Please (Paclitaxel coated balloon) |
| Taxus™Liberté™ | Active comparator | Device: Taxus™Liberté™ (Paclitaxel eluting stent) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Clinical evidence of stable or unstable angina or a positive functional study
- Single, stenotic de novo lesion in a native coronary artery, type A or selected B1 (see 4.3.1.1 Definition of lesion types)
- Diameter stenosis > 70% (visual estimate)
- Vessel diameter 2.5 - 3.5 mm
Key exclusion criteria (12 listed)
- Left ventricular ejection fraction of < 30%
- Visible thrombus proximal to the lesion
- Expection that treatment with devices other than PTCA will be required for this lesion.
- Stenosis is within a bypass graft
- Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated
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 |
|---|---|---|
| SeQuent®Please (Paclitaxel coated balloon)PCI of de-novo lesions | Device | Sequent®Please |
| Taxus™Liberté™ (Paclitaxel eluting stent)PCI of de-novo lesions | Device | Taxus™Liberté™ |
Primary outcome
Late lumen loss
Time frame: 6 months
Late lumen loss = MLD in-lesion initially - MLD in lesion after six months (after nitroglycerin in identical projections); assessment by an independent Core Lab.
5 secondary outcomes
Thrombotic occlusion of the target lesion
Time frame: 30 days, 6, 12, 24, 60 months
Revascularization of the target lesion
Time frame: 30 days, 6, 12, 24, 60 months
Myocardial infarction
Time frame: 30 days, 6, 12, 24, 60 months
Death
Time frame: 30 days, 6, 12, 24, 60 months
Combined clinical endpoint (MACE)
Time frame: 30 days, 6, 12, 24, 60 months
Results and safety
The study was stopped early (reason given: no suitable patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
Related trials for Coronary De-novo Stenoses
Not yet recruiting
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
Coronary Artery Disease, De Novo Stenosis Lesion
Active, not recruiting
STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) Trial
Drug-coated Balloon, Drug-eluting Stent
Not yet recruitingObservational study
The PICCOLETO XIII REVEAL-DCB Cohort A Study
Coronary Artery Disease, Coronary Stenosis
Recruiting
First-in-Human Study Using the SiroMax™ Sirolimus-Coated Balloon Catheter as a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to Treat Subjects Who Have Coronary Artery Disease (CAD) Involving In-Stent Restenosis (ISR) or an Unstented Lesion in a Small Coronary Vessel (DNSV).
Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Active, not recruiting
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
Coronary Artery Disease, Myocardial Ischemia
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.
Bruno Scheller, Prof. Dr. med principal investigator
Uniklinikum des Saarlandes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SeQuent®Please (Paclitaxel coated balloon) and Taxus™Liberté™ (Paclitaxel eluting stent) in people with Coronary De-novo Stenoses, 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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 25 Mar 2021. 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.
What does this phase mean?
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?
The study was stopped early (reason given: no suitable patients). 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 (time frame: 6 months). 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 25 Mar 2021.