The BLIMP Balloon in Coronary Interventions

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ClinicalTrials.gov Identifier: NCT03947398

Recruitment Status : Unknown

Verified March 2019 by Universitaire Ziekenhuizen Leuven.
Recruitment status was: Recruiting

First Posted : May 13, 2019

Last Update Posted : May 13, 2019

Sponsor:

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 Dinant Godinne - UCL Namur

University Ghent

University Hospital, Antwerp

Centre Hospitalier du Luxembourg

Information provided by (Responsible Party):

Universitaire Ziekenhuizen Leuven

Study Description

Brief Summary:

The purpose of this study is to investigate the effectivness of the Blimp Scoring balloon compared to current available CTO balloon catheters.

Condition or disease	Intervention/treatment	Phase
Percutaneous Coronary Intervention Chronic Total Occlusion of Coronary Artery	Device: BLIMP balloon Device: Low profile balloon	Not Applicable

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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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	128 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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.
Actual Study Start Date :	March 28, 2019
Estimated Primary Completion Date :	March 28, 2021
Estimated Study Completion Date :	March 28, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment with BLIMP first	Device: BLIMP balloon Using BLIMP balloon to cross lesion
Active Comparator: Treatment with low-profile balloon first	Device: Low profile balloon using low profile balloon to cross lesion

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Severe coronary lesion where microcatheter or dilatation balloon does not cross

Exclusion Criteria:

none

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03947398

Contacts

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Contact: Johan Bennett	479293854 ext 479293854	johan.bennett@uzleuven.be

Locations

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Belgium
Johan Bennett	Recruiting
Leuven, Brabant, Belgium, 3001
Contact: Johan Bennett 479293854 ext 479293854 johan.bennett@uzleuven.be
Sub-Investigator: Keir McCutcheon
ZOL Genk	Not yet recruiting
Genk, Belgium, 3600
Contact: Joseph Dens, MD, PhD +32 89 327193 jo.dens@zol.be
Contact: Nele Peeters +32 89 327193 nele.peeters@zol.be
Principal Investigator: Joseph Dens, MD, PhD
Sub-Investigator: Matthias Vrolix, MD
Sub-Investigator: Johan Van Lierde, MD

Sponsors and Collaborators