Coronary Artery DiseaseNCT01399463
Pressure-wire Guided PTCA: Drug Eluting Stent Versus Drug Eluting Balloon (WinDEB Study)
A study testing Angioplasty performed via Paclitaxel Eluting Balloon catheter and Angioplasty via DES in people with Coronary Artery Disease, run by Medical University of Vienna.
Trial summary
The aim of the study is to show the safety and efficacy of the SeQuent® Please (Drug Eluting Balloon or DEB) vs. commonly used Drug Eluting Stents in the treatment of small vessel disease and side branches by pressure wire guided percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Angioplasty performed via Paclitaxel Eluting Balloon catheter and Angioplasty via DES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 2011to not given
- 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 of at least 18 years of age.
- 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 must agree to undergo the angiographic 6-month and clinical follow-ups at 12 and 36 months.
- De novo coronary lesions including side branches in native coronary arteries (reference vessel between ≥ 2.0 and ≤ 3.0 mm, lesion length ≤ 25 mm as angiographically documented)
- 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, scintigraphy, MRT, or suspected based on angina pectoris.
- Fractional Flow Reserve (FFR) must be less or equal to 0.75.
Who cannot join
- Patients with a life expectancy of less than 12 months
- Patients that were treated with one or more DES during the last 12 months which would not allow 3-month dual antiplatelet therapy if the patient were randomized in the DEB treatment group.
- Patients who are obliged to be on dual antiplatelet aggregation therapy for more than 3 months following study inclusion
- Patients with acute (< 24 h) or recent (48 hours) myocardial infarction
- Patients with severe congestive heart failure or with severe heart failure NYHA IV or with severe valvular heart disease
- 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)
Show all 9Show fewer
- DES treated lesion(s) during the last 12 months.
- Thrombus burden (STEMI, NSTEMI) and/or total occlusion in the culprit segment
- In-segment stenosis of the native vessel within the 5 mm adjacent to the stent
About this study
Official title: Pressure Wire-guided Percutaneous Coronary Intervention of Small Vessels or Side Branches: Functional Outcome of Drug-Eluting Stent (DES) Versus Drug-Eluting Balloon (DEB) With Provisional Bare Metal Stent Implantation
The aim of the study is to show the safety and efficacy of the SeQuent® Please (Drug Eluting Balloon or DEB) vs. commonly used Drug Eluting Stents in the treatment of small vessel disease and side branches by pressure wire guided percutaneous coronary intervention.
Read the detailed description
This study is a randomized, prospective, multi-center, efficacy study with a DES control group assessing the 6-month loss in FFR in patients treated with the "matrix coated paclitaxel-eluting PTCA-balloon catheter" SeQuent® Please and commonly used DES for small vessel de novo and side branch lesions. 100 patients will be studied in total with two equivalent treatment groups DEB \& DES of 50 patients each.
- Conditions
- Coronary Artery Disease
- Being tested
- Angioplasty performed via Paclitaxel Eluting Balloon catheter, Angioplasty via DES
- Keywords
- Drug Eluting Stent, Drug Eluting Balloon, Fractional Flow Reserve, DES, DEB, FFR
- Medical subject headings
- Coronary Artery Disease, Dysequilibrium syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angioplasty performed via Paclitaxel Eluting Balloon catheterDevice
Angioplasty via DESDevice
Angioplasty performed via commonly used Drug Eluting Stents
| Study group | Role | What they receive |
|---|---|---|
| DEB + BMS | Experimental | Paclitaxel drug-eluting balloon (DEB) dilatation and bare metal stenting Receives: Device: Angioplasty performed via Paclitaxel Eluting Balloon catheter |
| Stenting with commonly used Drug Eluting Stents (DES) | Active comparator | Not described Receives: Device: Angioplasty via DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss in fractional flow reserve (FFR) at 6 months for both treatment groups
Measured: 6 month
Secondary outcomes (8)
Occurrence of acute (up to 48 hours), subacute (up to 30 days) and late stent thrombosis
Measured: acute: <48h; subacute: < 30days
NACCE rate at 30 days, 6 and 12 months
Measured: 30days, 6 and 12 month
Procedural success
Percent in-stent stenosis, in-segment stenosis, in-stent late lumen loss and in-segment late lumen loss at 6 months follow-up
Percent in-stent stenosis, in-segment stenosis, in-stent late lumen loss and in-segment late lumen loss at 6 months follow-up
Measured: 6 month
Angiographic in-stent restenosis rate of the target lesion (≥ 50 % stenosis) at 6 months from the procedure
Measured: 6 month
Angiographic in-segment stenosis rate of the target lesion (≥ 50 % stenosis) at 6 months from the procedure
Measured: 6 month
Indication for premature follow-up
Target vessel failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 N/A
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399463
- Sponsor's protocol ID
- MUWCard18022011
- Status last verified
- Jul 2011
- First submitted
- 20 Jul 2011
- Last updated
- 21 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Wire-guided Percutaneous Coronary Intervention of Small Vessels or Side Branches: Functional Outcome of Drug-Eluting Stent (DES) Versus Drug-Eluting Balloon (DEB) With Provisional Bare Metal Stent Implantation
- ClinicalTrials.gov ID
- NCT01399463
- Acronym / sponsor ID
- MUWCard18022011
- Conditions
- Coronary Artery Disease
- Keywords
- Drug Eluting Stent, Drug Eluting Balloon, Fractional Flow Reserve, DES, DEB, FFR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2011
- First posted
- 21 Jul 2011 (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 show the safety and efficacy of the SeQuent® Please (Drug Eluting Balloon or DEB) vs. commonly used Drug Eluting Stents in the treatment of small vessel disease and side branches by pressure wire guided percutaneous coronary intervention.
Detailed description
This study is a randomized, prospective, multi-center, efficacy study with a DES control group assessing the 6-month loss in FFR in patients treated with the "matrix coated paclitaxel-eluting PTCA-balloon catheter" SeQuent® Please and commonly used DES for small vessel de novo and side branch lesions. 100 patients will be studied in total with two equivalent treatment groups DEB \& DES of 50 patients each.
Study design
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEB + BMS | Experimental | Device: Angioplasty performed via Paclitaxel Eluting Balloon catheterPaclitaxel drug-eluting balloon (DEB) dilatation and bare metal stenting |
| Stenting with commonly used Drug Eluting Stents (DES) | Active comparator | Device: Angioplasty via DES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of at least 18 years of age.
- 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 must agree to undergo the angiographic 6-month and clinical follow-ups at 12 and 36 months.
- De novo coronary lesions including side branches in native coronary arteries (reference vessel between ≥ 2.0 and ≤ 3.0 mm, lesion length ≤ 25 mm as angiographically documented)
- 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, scintigraphy, MRT, or suspected based on angina pectoris.
Key exclusion criteria (9 listed)
- Patients with a life expectancy of less than 12 months
- Patients that were treated with one or more DES during the last 12 months which would not allow 3-month dual antiplatelet therapy if the patient were randomized in the DEB treatment group.
- Patients who are obliged to be on dual antiplatelet aggregation therapy for more than 3 months following study inclusion
- Patients with acute (< 24 h) or recent (48 hours) myocardial infarction
- Patients with severe congestive heart failure or with severe heart failure NYHA IV or with severe valvular heart disease
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 |
|---|---|---|
| Angioplasty performed via Paclitaxel Eluting Balloon catheter | Device | DEB + BMS |
| Angioplasty via DESAngioplasty performed via commonly used Drug Eluting Stents | Device | Stenting with commonly used Drug Eluting Stents (DES) |
Primary outcome
Loss in fractional flow reserve (FFR) at 6 months for both treatment groups
Time frame: 6 month
8 secondary outcomes
Occurrence of acute (up to 48 hours), subacute (up to 30 days) and late stent thrombosis
Time frame: acute: <48h; subacute: < 30days
NACCE rate at 30 days, 6 and 12 months
Time frame: 30days, 6 and 12 month
Procedural success
Percent in-stent stenosis, in-segment stenosis, in-stent late lumen loss and in-segment late lumen loss at 6 months follow-up
Time frame: 6 month
Angiographic in-stent restenosis rate of the target lesion (≥ 50 % stenosis) at 6 months from the procedure
Time frame: 6 month
Angiographic in-segment stenosis rate of the target lesion (≥ 50 % stenosis) at 6 months from the procedure
Time frame: 6 month
Indication for premature follow-up
Target vessel failure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Angioplasty performed via Paclitaxel Eluting Balloon catheter and Angioplasty via DES in people with Coronary Artery Disease, run by Medical University of Vienna.
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 9 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 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Loss in fractional flow reserve (FFR) at 6 months for both treatment groups (time frame: 6 month). 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 21 Jul 2011.