Percutaneous Coronary InterventionNCT03947398
The BLIMP Balloon in Coronary Interventions
A study testing BLIMP balloon and Low profile balloon in people with Percutaneous Coronary Intervention and Chronic Total Occlusion of Coronary Artery, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial summary
The purpose of this study is to investigate the effectivness of the Blimp Scoring balloon compared to current available CTO balloon catheters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention, Chronic Total Occlusion of Coronary Artery
- What is being tested?
- BLIMP balloon and Low profile balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesBelgium
- Study dates
- 28 Mar 2019to 28 Mar 2021
- 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
- Severe coronary lesion where microcatheter or dilatation balloon does not cross
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Prospective, Multi-Center Registry, Randomized Trial for Evaluation of Effectiveness of the Blimp Scoring Balloon in Lesions Not Crossable With Conventional Balloon or Microcatheter.
The purpose of this study is to investigate the effectivness of the Blimp Scoring balloon compared to current available CTO balloon catheters.
Read the detailed description
For this study two case situations are being considered.
6.1.1 Case Situation A Guidewire crossed the lesion, micro catheter does not cross
Case situation A is the circumstansis where a physician is using a guidewire in combination with a micro catheter. When in such case the guidewire is crossing at a certain moment of the procedure and the micro catheter not a balloon crossing attempt is one of the current common options as next step.
For the study the physician will go through following steps
- select alternating in 50% of these cases his current first choice regular balloon (≤ 1.5 (mm) OD) and in the other 50% of cases the Blimp.
- If first choice regular balloon does not cross select the Blimp and if the Blimp has been first choice select regular first choice balloon.
- If step 2 is not succesfull take a 6F guide extension and repeat sequence of step 1\&2.
- If step 3 is also not succesfull report how else succeeded (e.g. tonus, balloon rupture, carlino, rotablation, subintimal cross…) or not.
See also appendix I for a flow chart case situation A.
6.1.2 Case Situation B Small balloon catheter (≤ 1.5 (mm)) needed for procedure- no micro catheter used.
Case situation B is the circumstansis where a physician is in the stage of a procedure where he/ she would normally want to select a small balloon catheter ((≤ 1.5 (mm)) to cross an occluded or subtotlal stenotic segment of the coronary artery. When in such case the balloon catheter is not crossing the selection/ attempt with another balloon is one of the current common options as next step.
For the study the physician will go through following steps
- select alternating in 50% of these cases his current first choice regular balloon (≤ 1.5 (mm) OD) and in the other 50% of cases the Blimp.
- If first choice regular balloon does not cross select the Blimp and if the Blimp has been first choice select regular first choice balloon.
- If step 2 is not succesfull take a 6F guide extension and repeat sequence of step 1\&2.
- If step 3 is also not succesfull report how else succeeded (e.g. tonus, balloon rupture, carlino, rotablation, subintimal cross…) or not.See also appendix I for a flow chart of case situation B.
6.1.3 Use of the Blimp during the study
The Blimp should be used conform its Instruction For Use (IFU). Following techniques can be attemted to cross the lesion.
- Regular balloon crossing of lesion if no significant resistance is felt.
- Application of distal force/ push to the tip of Blimp against the proximal cap of the occlusion/subtotal lesion for 5-10 seconds to allow cap penetration due to spring principle of Blimp shaft.
- If no progressing in step 2 keep distal force/ push to the tip of the Blimp and inflate to 25-30 ATM to attempt wedging/ scoring of the proximal cap.
- Repeat step 2\&3 up to three times to see if proximal cap/ crossing progression is made.
- If after multiple attemps of step 2\&3 no progression is demonstrated it should be concluded that the Blimp was unsuccesfull in crossing.
6.1.4 Study population and number of subjects A total 128 patients which are being targeted for percutaneous coronary intervention are selected for this study. Pased on power calculations, 128 patiants are sufficient to demonstrate a statistical significant difference in outcome (P<0.05) with 80% power.
6.1.5 Inclusion/exclusion criteria Patients will be enrolled if they require percutaneous coronary intervention (PCI) procedure and
- During the case a micro catheter is being used which is not able to cross after crossing of the guidewire (case situation A).
- During the case a small balloon catheter (≤ 1.5 (mm) OD) is being used and is not able to cross the target lesion (case situation B) .
Patients which under normal conditions would be excluded for a PCI procedure by the hospital will be excluded from the study.
6.1.6 Rational and justification of chosen study design The Blimp is intended for balloon dilatation of a coronary artery subtotal lesion/occlusions.
Due to its
- very small profile
- high rated burst pressure and
- guidewire scoring element over the balloon the device has several features which can improve the crossabiltiy and initial dilation of severe occluded vessels. The study has been designed such to investigate in an objective and controlled manner if the Blimp Scoring balloon is providing an improved procedural success rate in these matters.
- Being tested
- BLIMP balloon, Low profile balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLIMP balloonDevice
Using BLIMP balloon to cross lesion
Low profile balloonDevice
using low profile balloon to cross lesion
| Study group | Role | What they receive |
|---|---|---|
| Treatment with BLIMP first | Experimental | Not described Receives: Device: BLIMP balloon |
| Treatment with low-profile balloon first | Active comparator | Not described Receives: Device: Low profile balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful crossing through lesion and dilatation with BLIMP or low profile balloon
passing of BLIMP or low profile balloon through lesion. If device passess it will be determined a successful outcome, if it does not pass, an unsuccesful outcome.
Measured: The primary outcome is a procedural assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start28 Mar 2019
- Primary completion28 Mar 2021
- Study completion28 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, AZ Sint-Jan AV, CHU de Charleroi, Jolimont, La Louviere, Centre Hospitalier Universitaire Saint Pierre, Onze Lieve Vrouwziekenhuis Aalst, Centre Hospitalier Universitaire UCLouvain Namur, University Ghent, University Hospital, Antwerp, Centre Hospitalier du Luxembourg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947398
- Sponsor's protocol ID
- S61686
- Status last verified
- Mar 2019
- First submitted
- 28 Mar 2019
- Last updated
- 27 Jan 2023
- Results posted
- No
- 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 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Registry, Randomized Trial for Evaluation of Effectiveness of the Blimp Scoring Balloon in Lesions Not Crossable With Conventional Balloon or Microcatheter.
- ClinicalTrials.gov ID
- NCT03947398
- Acronym / sponsor ID
- S61686
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, AZ Sint-Jan AV, CHU de Charleroi, Jolimont, La Louviere, Centre Hospitalier Universitaire Saint Pierre, Onze Lieve Vrouwziekenhuis Aalst, Centre Hospitalier Universitaire UCLouvain Namur, University Ghent, University Hospital, Antwerp, Centre Hospitalier du Luxembourg
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 28 Mar 2021 (actual)
- Study completion
- 28 Mar 2021 (actual)
- First posted
- 13 May 2019 (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.
The purpose of this study is to investigate the effectivness of the Blimp Scoring balloon compared to current available CTO balloon catheters.
Detailed description
For this study two case situations are being considered.
6.1.1 Case Situation A Guidewire crossed the lesion, micro catheter does not cross
Case situation A is the circumstansis where a physician is using a guidewire in combination with a micro catheter. When in such case the guidewire is crossing at a certain moment of the procedure and the micro catheter not a balloon crossing attempt is one of the current common options as next step.
For the study the physician will go through following steps
- select alternating in 50% of these cases his current first choice regular balloon (≤ 1.5 (mm) OD) and in the other 50% of cases the Blimp.
- If first choice regular balloon does not cross select the Blimp and if the Blimp has been first choice select regular first choice balloon.
- If step 2 is not succesfull take a 6F guide extension and repeat sequence of step 1\&2.
- If step 3 is also not succesfull report how else succeeded (e.g. tonus, balloon rupture, carlino, rotablation, subintimal cross…) or not.
See also appendix I for a flow chart case situation A.
6.1.2 Case Situation B Small balloon catheter (≤ 1.5 (mm)) needed for procedure- no micro catheter used.
Case situation B is the circumstansis where a physician is in the stage of a procedure where he/ she would normally want to select a small balloon catheter ((≤ 1.5 (mm)) to cross an occluded or subtotlal stenotic segment of the coronary artery. When in such case the balloon catheter is not crossing the selection/ attempt with another balloon is one of the current common options as next step.
For the study the physician will go through following steps
- select alternating in 50% of these cases his current first choice regular balloon (≤ 1.5 (mm) OD) and in the other 50% of cases the Blimp.
- If first choice regular balloon does not cross select the Blimp and if the Blimp has been first choice select regular first choice balloon.
- If step 2 is not succesfull take a 6F guide extension and repeat sequence of step 1\&2.
- If step 3 is also not succesfull report how else succeeded (e.g. tonus, balloon rupture, carlino, rotablation, subintimal cross…) or not.See also appendix I for a flow chart of case situation B.
6.1.3 Use of the Blimp during the study
The Blimp should be used conform its Instruction For Use (IFU). Following techniques can be attemted to cross the lesion.
- Regular balloon crossing of lesion if no significant resistance is felt.
- Application of distal force/ push to the tip of Blimp against the proximal cap of the occlusion/subtotal lesion for 5-10 seconds to allow cap penetration due to spring principle of Blimp shaft.
- If no progressing in step 2 keep distal force/ push to the tip of the Blimp and inflate to 25-30 ATM to attempt wedging/ scoring of the proximal cap.
- Repeat step 2\&3 up to three times to see if proximal cap/ crossing progression is made.
- If after multiple attemps of step 2\&3 no progression is demonstrated it should be concluded that the Blimp was unsuccesfull in crossing.
6.1.4 Study population and number of subjects A total 128 patients which are being targeted for percutaneous coronary intervention are selected for this study. Pased on power calculations, 128 patiants are sufficient to demonstrate a statistical significant difference in outcome (P<0.05) with 80% power.
6.1.5 Inclusion/exclusion criteria Patients will be enrolled if they require percutaneous coronary intervention (PCI) procedure and
- During the case a micro catheter is being used which is not able to cross after crossing of the guidewire (case situation A).
- During the case a small balloon catheter (≤ 1.5 (mm) OD) is being used and is not able to cross the target lesion (case situation B) .
Patients which under normal conditions would be excluded for a PCI procedure by the hospital will be excluded from the study.
6.1.6 Rational and justification of chosen study design The Blimp is intended for balloon dilatation of a coronary artery subtotal lesion/occlusions.
Due to its
- very small profile
- high rated burst pressure and
- guidewire scoring element over the balloon the device has several features which can improve the crossabiltiy and initial dilation of severe occluded vessels. The study has been designed such to investigate in an objective and controlled manner if the Blimp Scoring balloon is providing an improved procedural success rate in these matters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with BLIMP first | Experimental | Device: BLIMP balloon |
| Treatment with low-profile balloon first | Active comparator | Device: Low profile balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Severe coronary lesion where microcatheter or dilatation balloon does not cross
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| BLIMP balloonUsing BLIMP balloon to cross lesion | Device | Treatment with BLIMP first |
| Low profile balloonusing low profile balloon to cross lesion | Device | Treatment with low-profile balloon first |
Primary outcome
Successful crossing through lesion and dilatation with BLIMP or low profile balloon
Time frame: The primary outcome is a procedural assessment
passing of BLIMP or low profile balloon through lesion. If device passess it will be determined a successful outcome, if it does not pass, an unsuccesful outcome.
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 27 Jan 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BLIMP balloon and Low profile balloon in people with Percutaneous Coronary Intervention and Chronic Total Occlusion of Coronary Artery, run by Universitaire Ziekenhuizen KU Leuven at 2 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 1 inclusion and 1 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 27 Jan 2023. 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 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?
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?
Successful crossing through lesion and dilatation with BLIMP or low profile balloon (time frame: The primary outcome is a procedural assessment). 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 27 Jan 2023.