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

NCT03518645 | Completed

• 1 other identifier: OPreNBiS
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Angina, Unstable; Angina, Stable

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Procedural success defined as successful delivery of the scaffold.

  During the index procedure

• Need for post-dilatation after initial OCT.

  During the index procedure

• Scaffold apposition after post-dilatation.

  During the index procedure

• Periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation.

  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).

  During the index procedure

Study Arms (2)

OPN strategy

EXPERIMENTAL

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

standard strategy

ACTIVE COMPARATOR

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

Device: standard strategy

Interventions

OPN strategy DEVICE

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

OPN strategy

standard strategy DEVICE

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

standard strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• KCRI: lead
• SIS Medical AG: collaborator

Study Sites (1)

Luzerner Kantonsspital

Lucerne, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 32076567 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Unstable; Angina, Stable; Angina Pectoris

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Florim Cuculi, MD, PhD

  Luzerner Kantonsspital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 8, 2018
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 29, 2018
• Last Updated: May 8, 2018

Record last verified: 2018-05

Locations

CH (1)