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 (Bioresorbable Vascular Scaffold).

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: Unknown
• Conditions: Coronary Artery Disease; Stable Angina; Unstable Angina; Angina
• Intervention / Treatment: Device: Predilatation with OPN NC balloon catheter.; Device: Absorb BVS implantation.; Procedure: Treated segment visualization by OCT.; Other: Clinical FU at 12 months.; Device: Predilatation with standard compliant balloon.

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 ® 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): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Luzern, Switzerland, 6000
    • Luzernen Kantonsspital, Spitalstrasse 16

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
Other: OPN strategy (study group); Interventions planned in this arm are as follows: Predilatation with OPN NC balloon catheter.; Absorb BVS implantation.; Treated segment visualization by OCT.; Clinical FU at 12 months.	Device: Predilatation with OPN NC balloon catheter.; Target lesion will be prepared by predilatation with OPN NC balloon catheter.; Device: Absorb BVS implantation.; After lesion preparation implantation of BVS Absorb scaffold will be performed.; Procedure: Treated segment visualization by OCT.; Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT).; Other: Clinical FU at 12 months.; All patients will be clinically followed for 12 months.
Other: Standard strategy (control group); Interventions planned in this arm are as follows: Predilatation with standard compliant balloon.; Absorb BVS implantation.; Treated segment visualization by OCT.; Clinical FU at 12 months.	Device: Absorb BVS implantation.; After lesion preparation implantation of BVS Absorb scaffold will be performed.; Procedure: Treated segment visualization by OCT.; Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT).; Other: Clinical FU at 12 months.; All patients will be clinically followed for 12 months.; Device: Predilatation with standard compliant balloon.; Target lesion will be prepared by predilatation with standard balloon catheter (compliant).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section	Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure.	Participants will be followed for the duration of index procedure, an expected average of 1 hour.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success defined as successful delivery of the scaffold		Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Need for post-dilatation after implantation of the scaffold		Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Scaffold apposition after post-dilatation	Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure.	Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Frequency and total number of periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation,		Participants will be followed for the duration of index procedure, an expected average of 1 hour.

Other Outcome Measures

Outcome Measure	Time Frame
Number of patients with diagnosis of periprocedural myocardial infarction defined as 5x upper reference level elevation of high sensitive Troponin I (in patients with normal pre-procedural Troponin)	Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Number of patients with diagnosis of in-stent restenosis requiring revascularization within 12 months post-procedure	12 month folow up
Rate of stent thrombosis according the ARC criteria within 12 months post procedure	12 month follow up
Death or myocardial infarction within 12 months post-procedure	12 month follow up

Collaborators and Investigators

• Sponsor: SIS Medical AG
• Investigators: Principal Investigator: Florim Cuculi, Prof. dr

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimate): June 11, 2015

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 30, 2017
• Last Verified: April 1, 2017

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