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

NCT ID: NCT03518645

Last Updated: 2018-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2018-03-29

Brief 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.

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)

Conditions

Coronary Artery Disease; Angina, Unstable; Angina, Stable

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

OPN strategy

Intervention Type: DEVICE

Predilatation with OPN balloon will be performed as a lesion preparation for BVS Absorb implantation.

standard strategy

Predilatation with standard coronary balloon will be performed for lesion preparation for BVS Absorb implantation - standard strategy of lesion preparation.

Group Type: ACTIVE_COMPARATOR

standard strategy

Intervention Type: DEVICE

Predilatation with standard balloon will be performed as a lesion preparation for BVS Absorb implantation.

Interventions

OPN strategy

Predilatation with OPN balloon will be performed as a lesion preparation for BVS Absorb implantation.

Intervention Type: DEVICE

standard strategy

Predilatation with standard balloon will be performed as a lesion preparation for BVS Absorb implantation.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SIS Medical AG

INDUSTRY

Sponsor Role: collaborator

KCRI

OTHER

Sponsor Role: lead

Responsible Party

Wojciech Zasada

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Florim Cuculi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Luzerner Kantonsspital

Locations

Luzerner Kantonsspital

Lucerne, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 32076567 (View on PubMed)

Other Identifiers

OPreNBiS

Identifier Type: -

Identifier Source: org_study_id