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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Angina, Stable; Angina, Unstable
• Intervention / Treatment: Device: OPN strategy; Device: standard strategy

Detailed 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)

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Luzern, Switzerland
    • Luzerner Kantonsspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OPN strategy; The OPN NC Super High Pressure PTCA Balloon will be used as the study device for lesion preparation for BVS Absorb implantation - OPN strategy of lesion preparation. This balloon has a twin layer balloon construction, which allows a very high pressure resistance of 35 bar. The balloon has a 0.016'' lesion entry profile and is available in sizes between 1.5 and 4.5 mm and lengths of 10, 15 and 20 mm.	Device: OPN strategy; Predilatation with OPN balloon will be performed as a lesion preparation for BVS Absorb implantation.
Active Comparator: standard strategy; Predilatation with standard coronary balloon will be performed for lesion preparation for BVS Absorb implantation - standard strategy of lesion preparation.	Device: standard strategy; Predilatation with standard balloon will be performed as a lesion preparation for BVS Absorb implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Need for post-dilatation after initial OCT.	The frequency of post-dilatation will be compared in both study groups.	During the index procedure
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: KCRI
• Collaborators: SIS Medical AG
• Investigators: Principal Investigator: Florim Cuculi, MD, PhD, Luzerner Kantonsspital

Publications and helpful links

General Publications

• Cuculi F, Bossard M, Zasada W, Moccetti F, Voskuil M, Wolfrum M, Malinowski KP, Toggweiler S, Kobza R. Performing percutaneous coronary interventions with predilatation using non-compliant balloons at high-pressure versus conventional semi-compliant balloons: insights from two randomised studies using optical coherence tomography. Open Heart. 2020 Jan 23;7(1):e001204. doi: 10.1136/openhrt-2019-001204. eCollection 2020.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): March 29, 2018

Study Registration Dates

• First Submitted: April 20, 2018
• First Submitted That Met QC Criteria: May 7, 2018
• First Posted (Actual): May 8, 2018

Study Record Updates

• Last Update Posted (Actual): May 8, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Angina; Stable; Unstable; OPN NC
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris; Angina, Stable; Angina, Unstable
• Other Study ID Numbers: OPreNBiS