Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds

Coronary Artery Disease Clinical Trial

— OPreNBiS  

Official title:

Optimal Lesion Preparation With Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) -OPRENBIS Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518645
• Other study ID #: OPreNBiS
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: March 29, 2018

Study information

• Verified date: May 2018
• Source: KCRI
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS.

Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly reduced. This is expected to result in better short- and long-term outcomes.

Description:

Study design:

Following pre-dilatation a BVS will be implanted and optical coherence tomography (OCT) will be performed in all patients. After OCT post-dilatation with non-compliant balloons might be performed if this is considered necessary by the treating interventionist. Final OCT will be performed in all patients. 1:1 Randomization of two strategies before the implantation of bioresorbable scaffolds:

• OPN strategy (study group): pre-dilatation with OPN® NC (non-compliant) Super High Pressure PTCA (percutaneous transluminal coronary angioplasty) balloons

• standard strategy (control group): pre-dilatation with a standard (compliant) balloon

Enrolment:

Randomization of 50 patients

• 25 in the OPN strategy (study group)

• 25 in the standard strategy (control group)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 29, 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years.

• Able and willing to give informed consent.

• Willing to comply with specified follow-up evaluations.

• Clinical manifestation of coronary artery disease: stable angina, unstable angina or non-ST-elevation myocardial infarction.

• De novo lesion.

• Angiographic diameter stenosis > 70 % and/or fractional flow reserve <0.80.

• Vessel diameter between 2.5 and 4.0 mm.

• One- or two vessel disease (defined as diameter stenosis > 70 % in vessels with a diameter > 2.5 mm).

• Up to two lesions in one or two vessels can be treated.

Exclusion Criteria:

Patient characteristics

• Pregnant or nursing patient or planned pregnancy in the period up to 1 year following the index procedure.

• Patient with contraindication for 12 months of dual antiplatelet therapy.

• ST-elevation myocardial infarction.

• Any contraindication to the implantation of BVS. Lesion characteristics

• Visible thrombus in coronary angiography

• Chronic total occlusion

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• OPN strategy
Predilatation with OPN balloon will be performed as a lesion preparation for BVS Absorb implantation.
• standard strategy
Predilatation with standard balloon will be performed as a lesion preparation for BVS Absorb implantation.

Locations

Country	Name	City	State
Switzerland	Luzerner Kantonsspital	Luzern

Sponsors (2)

Lead Sponsor	Collaborator
KCRI	SIS Medical AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apposition of bioresorbable scaffold immediately after stent implantation following: pre-dilatation with OPN vs. pre-dilatation with standard balloons.	Stent apposition will be assessed based on OCT (optical coherence tomography) visualization.	During the index procedure
Secondary	Procedural success defined as successful delivery of the scaffold.	The frequency of procedural success will be compared in both study groups.	During the index procedure
Secondary	Need for post-dilatation after initial OCT.	The frequency of post-dilatation will be compared in both study groups.	During the index procedure
Secondary	Scaffold apposition after post-dilatation.	The scaffold apposition after post-dilatation will be compared based on OCT assessment in both study groups.	During the index procedure
Secondary	Periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation.	The frequency of periprocedural complications as dissection, slow-flow, no flow and dissection requiring additional stent implantation will be compared separately in both study group.	During the index procedure
Secondary	Periprocedural myocardial infarction defined as 5x upper reference level elevation of high sensitive Troponin I (in patients with normal pre-procedural Troponin).	The frequency of periprocedural myocardial infarction will be compared in both study groups.	During the index procedure
Secondary	In-stent restenosis requiring revascularization within 12 months post-procedure.	The frequency of in-stent restenosis requiring revascularization will be compared in both study groups in 12 months follow-up.	12 months after the index procedure
Secondary	Rate of stent thrombosis according the ARC (academic research consortium) criteria within 12 months post procedure.	The frequency of stent thrombosis will be compared in both study groups in 12 months follow-up.	12 months after the index procedure
Secondary	Death or myocardial infarction within 12 months post procedure.	The frequency of death and myocardial infarction will be compared separately in both study groups in 12 months follow-up.	12 months after the index procedure