- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03947398
The BLIMP Balloon in Coronary Interventions
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Johan Bennett
- Phone Number: 479293854 479293854
- Email: johan.bennett@uzleuven.be
Study Locations
-
-
-
Genk, Belgium, 3600
- ZOL Genk
-
-
Brabant
-
Leuven, Brabant, Belgium, 3001
- Johan Bennett
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Severe coronary lesion where microcatheter or dilatation balloon does not cross
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment with BLIMP first
|
Using BLIMP balloon to cross lesion
|
Active Comparator: Treatment with low-profile balloon first
|
using low profile balloon to cross lesion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
The primary outcome is a procedural assessment
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- S61686
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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