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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02468960
• Other study ID #: OPreNBiS
• Status: Active, not recruiting
• Phase: N/A
• First received: March 4, 2015
• Last updated: October 30, 2017
• Start date: March 2015
• Est. completion date: December 2018

Study information

• Verified date: April 2017
• Source: SIS Medical AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: December 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina
• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stable Angina
• Unstable Angina

Intervention

Device:
• Predilatation with OPN NC balloon catheter.
Target lesion will be prepared by predilatation with OPN NC balloon catheter.
• Predilatation with standard compliant balloon.
Target lesion will be prepared by predilatation with standard balloon catheter (compliant).
• 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.

Locations

Country	Name	City	State
Switzerland	Luzernen Kantonsspital, Spitalstrasse 16	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
SIS Medical AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	Number of patients with diagnosis of in-stent restenosis requiring revascularization within 12 months post-procedure		12 month folow up
Other	Rate of stent thrombosis according the ARC criteria within 12 months post procedure		12 month follow up
Other	Death or myocardial infarction within 12 months post-procedure		12 month follow up
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.