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

Primary Purpose

Coronary Artery Disease, Angina, Unstable Angina

Status

Unknown status

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Predilatation with OPN NC balloon catheter.

Predilatation with standard compliant balloon.

Absorb BVS implantation.

Treated segment visualization by OCT.

Clinical FU at 12 months.

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, OPN NC, Angina, Stable, Unstable

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Luzernen Kantonsspital, Spitalstrasse 16

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

OPN strategy (study group)

Standard strategy (control group)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Procedural success defined as successful delivery of the scaffold

Need for post-dilatation after implantation of the scaffold

Scaffold apposition after post-dilatation

Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure.

Frequency and total number of periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation,

Full Information

NCT ID

NCT02468960

First Posted

March 4, 2015

Last Updated

October 30, 2017

Sponsor

SIS Medical AG

1. Study Identification

Unique Protocol Identification Number

NCT02468960

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

February 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SIS Medical AG

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Angina, Unstable Angina, Stable Angina

Keywords

Coronary Artery Disease, OPN NC, Angina, Stable, Unstable

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OPN strategy (study group)

Arm Type

Other

Arm Description

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.

Arm Title

Standard strategy (control group)

Arm Type

Other

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Predilatation with OPN NC balloon catheter.

Intervention Description

Target lesion will be prepared by predilatation with OPN NC balloon catheter.

Intervention Type

Device

Intervention Name(s)

Predilatation with standard compliant balloon.

Intervention Description

Target lesion will be prepared by predilatation with standard balloon catheter (compliant).

Intervention Type

Device

Intervention Name(s)

Absorb BVS implantation.

Intervention Description

After lesion preparation implantation of BVS Absorb scaffold will be performed.

Intervention Type

Procedure

Intervention Name(s)

Treated segment visualization by OCT.

Intervention Description

Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT).

Intervention Type

Other

Intervention Name(s)

Clinical FU at 12 months.

Intervention Description

All patients will be clinically followed for 12 months.

Primary Outcome Measure Information:

Title

Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section

Description

Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure.

Time Frame