Intra-patient Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT (Optical Coherence Tomography) Follow up

Coronary Artery Disease Clinical Trial

Official title:

Intra-patient Randomized Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT Follow up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785237
• Other study ID #: FRIENDLY OCT
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: January 2019
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent

Description:

The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged = 18 years

• Signature of informed consent

• Patients with angina and a clinical indication for coronary revascularisation with a drug-eluting stent

• Presence of at least 2 lesions to be revascularised with similar angiographic characteristics

• Reference lesion diameter with at most a difference of 0.5 mm

• Maximum difference in lesion length of 10 mm

• Lesions able to be treated with only 1 stent

Exclusion Criteria:

• Lesions due to restenosis

• Lesions in saphenous vein grafts

• STE-ACS ( ST elevation- Acute Coronary Syndrome)

• Cardiogenic shock

• Dual antiplatelet therapy contraindication for> 3 months

• Follow-up catheterisation contraindicated

• Chronic kidney failure with creatinine > 2 mg/dL

• Allergy to iodinated contrast agents

• Serious complication from vascular access in previous catheterisation

• Ineligible for evaluation via optical coherence tomography

• Lesion located <5 mm from aorto-ostial junction

• Severe proximal angulation >90º

• Bifurcation lesion requiring a strategy with two stents

• Angiographic characteristics that promote stent malposition

• Aneurysm or coronary artery ectasia

• Presence of a thrombus classed as TIMI (Thrombolysis In Myocardial Infarction )2 flow or higher

• Severe calcification, in particular in cases of calcium spike

• Severe lesion angulation

• Inability to do reliable follow-up, in the investigator's opinion

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Coroflex® ISAR Drug-eluting stent
Coroflex® ISAR Drug-eluting stent and an Ultimaster® Drug-eluting stent in the second lesion.
• Ultimaster® Drug-eluting stent
Ultimaster® Drug-eluting stent and a Coroflex® ISAR Drug-eluting stent in the second lesion.

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Universitari Vall d`Hebron	Barcelona
Spain	Hospital de León	León

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	B.Braun Surgical SA

Country where clinical trial is conducted

Spain, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of early coating on the struts of the Coroflex® ISAR Drug-eluting stent versus Ultimaster® - Drug eluting stent at 3 months OCT after stent implantation.		3 months
Primary	Percentage of covered struts at 3 months OCT after stent implantation.		3 months
Primary	Percentage of stents with =3% of uncovered struts at 3 months OCT after stent implantation.		3 months
Primary	Percentage of uncovered struts =3% at 3 months OCT after stent implantation.		3 months
Primary	Number of transversal sections with a percentage (rate of uncovered struts/ total number of struts) > 30 % at 3 months OCT after stent implantation.		3 months
Secondary	Percentage of covered struts, at 1 month, 2 months and 3 months OCT after stent implantation.		1 month and 2 months and 3 months
Secondary	Total Tissue coverage at 1month, 2 months and 3 months OCT after stent implantation.		1 month and 2 months and 3 months
Secondary	Mean thickness of struts tissue coverage at 1 month, 2 months and 3 months OCT after stent implantation.		1 month and 2 months and 3 months
Secondary	MACE (Major Adverse Cardiac Events) at 30 days, 3 months, 6 months and 12 months.		30 days and 3 months and 6 months and 12 months
Secondary	Target lesion revascularization and target vessel revascularization at 30 days, 3 months, 6 months and 12 months OCT after stent implantation .		30 days and 3 months and 6 months and 12 months
Secondary	Percentage of stent malapposition at 1 month and 3 months OCT after stent implantation.		1 month and 2 months and 3 months
Secondary	Percentage of struts malapposition at 1 month and 3 months OCT after stent implantation.		1 month and 2 months and 3 months
Secondary	Percentage of struts malapposition> 260 µm at 1 month and 3 months OCT after stent implantation.		1 month and 2 months and 3 months
Secondary	Percentage of stents with any malapposition strut > 260 µm at 1 month and 3 months OCT after stent implantation.		1 month and 2 months and 3 months
Secondary	Healing Score at 1 month and 3 months OCT after stent implantation .		1 month and 2 months and 3 months