Coronary Artery DiseaseWEDGESNCT05019443
WEDGES: Coronary Lesion Preparation With Enhanced Dilatation for Good Expansion of Stent: Assessment of a New Scoring Balloon by Quantitative Stent Enhanced Visualization
A study testing Wedge Scoring Balloon and Conventional Balloon in people with Coronary Artery Disease, run by Stephane Carlier at 5 sites in Belgium.
Trial summary
Stent under-expansion during percutaneous coronary intervention (PCI) is one of the suboptimal results associated with a higher risk of restenosis and thrombosis. In order to obtain an optimal stent expansion, especially in lesions with calcific or fibrotic plaque, the appropriate lesion preparation before stent… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Wedge Scoring Balloon and Conventional Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesBelgium
- Study dates
- 1 Jan 2020to 30 Oct 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient written consent is given A de novo lesion
- Mild to moderate burden of calcifications detected on two orthogonal views using normal radiation power
Who cannot join
- Patient <18 years old
- Pregnant female
- Contraindication to dual antiplatelet therapy
- Thrombocytopenia <100 000
- Major surgical intervention planned
- Significant left main lesion
Show all 13Show fewer
- Bifurcating lesion with a significant side branch to be treated
- Lesion length > 25 mm
- Chronic total occlusion
- Lesion with heavy calcifications where a rotational atherectomy or lithotripsy should be planned
- Lesion in a graft
- In-stent restenosis lesion
- Lesion responsible of a STEMI
Trial locations and contacts
5 sites in 1 country.
Chadi Ghafari contact
5 sites in 1 country
Belgium5 sites, 5 recruiting
- Recruiting
UZ Genk
Genk, 3600
Jo Dens
- Recruiting
UZ Ghent
Ghent, 9000
Peter Kayaert
- Recruiting
CHU Jolimont
La Louvière, 7100
Claudiu Ungureanu
- Recruiting
CHU Liège
Liège, 4000
Lancelotti
- Recruiting
CHU Ambroise Paré
Mons, 7000
Stéphane Carlier, stephane.carlier@umons.ac.be
About this study
Official title: WEDGES: a Prospective, Multi-center Randomized Trial for the Evaluation of Coronary Lesion Preparation With Enhanced Dilatation for Good Expansion of Stent: Assessment of a New Scoring Balloon by Quantitative Stent Enhanced Visualization
Stent under-expansion during percutaneous coronary intervention (PCI) is one of the suboptimal results associated with a higher risk of restenosis and thrombosis. In order to obtain an optimal stent expansion, especially in lesions with calcific or fibrotic plaque, the appropriate lesion preparation before stent implantation is a crucial phase.
For this, different devices are used in everyday practices, including non-compliant balloon (NC), scoring / cutting balloons or rotational atherectomy; however, their effectiveness depends on the experience and skill of the operator. The purpose of this study is to assess the feasibility, efficacy and safety of a novel scoring balloon intended to treat calcific or fibrotic plaque of a coronary lesion
- Conditions
- Coronary Artery Disease
- Being tested
- Wedge Scoring Balloon, Conventional Balloon
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wedge Scoring BalloonDevice
Scoring balloon
Conventional BalloonDevice
Conventional balloon
| Study group | Role | What they receive |
|---|---|---|
| Conventional balloon predilation | Active comparator | the target lesion can be prepared according to standard clinical practice using SC balloons sized 0.8-1:1. Stenting using a drug-eluting stent (DES) is performed and the inflation pressure for delivery is noted, as well as the expected balloon diameter at that pressure. 2 enhanced stent imaging acquisitions (StentBoost or equivalent depending on the X-ray system used), are acquired in 2 orthogonal views. Post dilatation can be performed at operator discretion followed by a final acquisition of 2 similar orthogonal views with enhanced stent imaging. Intravascular imaging is left to the operator's discretion and is encouraged Receives: Device: Conventional Balloon |
| Scoring balloon predilation | Experimental | the target lesion must be prepared with a scoring balloon (SC) inflated 3 times at nominal pressure. To allow the scoring balloon to cross the lesion, it might be necessary to predilate with a small compliant balloon. The size of the scoring balloon to be used for is based on the size of the vessel. Stenting using a DES is performed and the inflation pressure for delivery is noted, as well as the expected balloon diameter at that pressure. 2 enhanced stent imaging acquisitions (StentBoost or equivalent depending on the X-ray system used), are acquired in 2 orthogonal views. Post dilatation can be performed at operator discretion followed by a final acquisition of 2 similar orthogonal views with enhanced stent imaging. Intravascular imaging is left to the operator's discretion and is encouraged Receives: Device: Wedge Scoring Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent expansion in calcified lesions assessed by stent diameter calculation using quantitative and intravascular analysis after lesion preparation using a scoring balloon is superior to conventional lesion preparation
The measure of stent expansion in calcified coronary lesions as assessed by quantitative coronary angiography, enhanced stent imaging and intravascular ultrasound after lesion preparation using the novel scoring semi-compliant and noncompliant balloons are superior (p<0.05) to semi compliant and non-compliant balloons.
Measured: Intravascular ultrasound (IVUS) or quantitative analysis is directly done after procedure
Secondary outcomes (3)
Rate of successful predilatation of calcified lesions of a scoring semi-compliant/non-compliant balloon and semi-compliant (SC)/ non-compliant (NC) balloon
Measured: Directly after procedure
Rate of residual under-expansion of stent after post-dilatation with a non-compliant balloon
Measured: Directly after procedure
Rate of procedural complication (composite of cardiac death, myocardial infarction, coronary artery perforation and cardiac tamponade) of a scoring balloon and a SC/NC balloon followed by stenting.
Measured: 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Jan 2020
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stephane Carlier
- Sponsor type
- University, hospital or other
- Collaborators
- BrosMed Medical Co., Ltd, University of Mons
- Responsible party
- Sponsor-investigator, Stephane Carlier, University of Mons
- Investigators
- Stéphane Carlier, Study director, University of Mons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019443
- Sponsor's protocol ID
- 007
- Acronym
- WEDGES
- Status last verified
- Aug 2021
- First submitted
- 13 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WEDGES: a Prospective, Multi-center Randomized Trial for the Evaluation of Coronary Lesion Preparation With Enhanced Dilatation for Good Expansion of Stent: Assessment of a New Scoring Balloon by Quantitative Stent Enhanced Visualization
- ClinicalTrials.gov ID
- NCT05019443
- Acronym / sponsor ID
- WEDGES / 007
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stephane CarlierUniversity, hospital or other
- Collaborators
- BrosMed Medical Co., Ltd, University of Mons
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 24 Aug 2021 (actual)
- 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.
Stent under-expansion during percutaneous coronary intervention (PCI) is one of the suboptimal results associated with a higher risk of restenosis and thrombosis. In order to obtain an optimal stent expansion, especially in lesions with calcific or fibrotic plaque, the appropriate lesion preparation before stent implantation is a crucial phase.
For this, different devices are used in everyday practices, including non-compliant balloon (NC), scoring / cutting balloons or rotational atherectomy; however, their effectiveness depends on the experience and skill of the operator. The purpose of this study is to assess the feasibility, efficacy and safety of a novel scoring balloon intended to treat calcific or fibrotic plaque of a coronary lesion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional balloon predilation | Active comparator | Device: Conventional Balloonthe target lesion can be prepared according to standard clinical practice using SC balloons sized 0.8-1:1. Stenting using a drug-eluting stent (DES) is performed and the inflation pressure for delivery is noted, as well as the expected balloon diameter at that pressure. 2 enhanced stent imaging acquisitions (StentBoost or equivalent depending on the X-ray system used), are acquired in 2 orthogonal views. Post dilatation can be performed at operator discretion followed by a final acquisition of 2 similar orthogonal views with enhanced stent imaging. Intravascular imaging is left to the operator's discretion and is encouraged |
| Scoring balloon predilation | Experimental | Device: Wedge Scoring Balloonthe target lesion must be prepared with a scoring balloon (SC) inflated 3 times at nominal pressure. To allow the scoring balloon to cross the lesion, it might be necessary to predilate with a small compliant balloon. The size of the scoring balloon to be used for is based on the size of the vessel. Stenting using a DES is performed and the inflation pressure for delivery is noted, as well as the expected balloon diameter at that pressure. 2 enhanced stent imaging acquisitions (StentBoost or equivalent depending on the X-ray system used), are acquired in 2 orthogonal views. Post dilatation can be performed at operator discretion followed by a final acquisition of 2 similar orthogonal views with enhanced stent imaging. Intravascular imaging is left to the operator's discretion and is encouraged |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient written consent is given A de novo lesion
- Mild to moderate burden of calcifications detected on two orthogonal views using normal radiation power
Key exclusion criteria (13 listed)
- Significant left main lesion
- Bifurcating lesion with a significant side branch to be treated
- Lesion length > 25 mm
- Chronic total occlusion
- Lesion with heavy calcifications where a rotational atherectomy or lithotripsy should be planned
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 |
|---|---|---|
| Wedge Scoring BalloonScoring balloon | Device | Scoring balloon predilation |
| Conventional BalloonConventional balloon | Device | Conventional balloon predilation |
Primary outcome
Stent expansion in calcified lesions assessed by stent diameter calculation using quantitative and intravascular analysis after lesion preparation using a scoring balloon is superior to conventional lesion preparation
Time frame: Intravascular ultrasound (IVUS) or quantitative analysis is directly done after procedure
The measure of stent expansion in calcified coronary lesions as assessed by quantitative coronary angiography, enhanced stent imaging and intravascular ultrasound after lesion preparation using the novel scoring semi-compliant and noncompliant balloons are superior (p<0.05) to semi compliant and non-compliant balloons.
3 secondary outcomes
Rate of successful predilatation of calcified lesions of a scoring semi-compliant/non-compliant balloon and semi-compliant (SC)/ non-compliant (NC) balloon
Time frame: Directly after procedure
Rate of residual under-expansion of stent after post-dilatation with a non-compliant balloon
Time frame: Directly after procedure
Rate of procedural complication (composite of cardiac death, myocardial infarction, coronary artery perforation and cardiac tamponade) of a scoring balloon and a SC/NC balloon followed by stenting.
Time frame: 1 month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Chadi Ghafari contact
Stéphane Carlier study director
University of Mons
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wedge Scoring Balloon and Conventional Balloon in people with Coronary Artery Disease, run by Stephane Carlier at 5 sites in Belgium.
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 2 inclusion and 13 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 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Carlier (0032475812765, stephane.carlier@umons.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent expansion in calcified lesions assessed by stent diameter calculation using quantitative and intravascular analysis after lesion preparation using a scoring balloon is superior to conventional lesion preparation (time frame: Intravascular ultrasound (IVUS) or quantitative analysis is directly done after procedure). 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 24 Aug 2021.