Collection of Information on the long-term results of treatment with the Supraflex™ Cruz drug-releasing blood vessel scaffold

Not Applicable

Completed

• Conditions: Atherothrombosis; Circulatory System

• Registration Number: ISRCTN39751665
• Lead Sponsor: Sahajanand Medical Technologies Pvt. Ltd (SMT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-01
• Study Completion: 2023-01-10
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1904

Inclusion Criteria

1. Aged 18 years or older
2. Symptomatic coronary disease
3. Clinical indication for PCI and stenting of at least one coronary lesion visually confirmed on coronary angiography
4. Only Supraflex Cruz stent(s) is/are to be implanted into the coronary vasculature during the index procedure
5. Give informed consent to participate in this registry and sign the informed consent form approved by the institutional review board of each registry site before the index PCI
6. Agree to undergo all clinical follow-up procedures specified in the study protocol (S-FLEX UK-II) for this registry

Exclusion Criteria

1. Cardiogenic shock.
2. Pregnant or possibly pregnant
3. Known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, sirolimus or contrast media
4. Scheduled to undergo elective surgery within 12 months post-index PCI
5. Currently participating in a clinical study of another drug or medical device and in whom assessment of the primary endpoint of that study has not been completed or clinically interferes with the endpoints of this registry
6. Mental incapacity, unwillingness or language barrier precluding understanding of the registry procedure or cooperation with registry site personnel

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The safety and efficacy of the Supraflex Cruz stent measured through patient interviews and the review of medical notes at the 12 month follow up

Secondary Outcome Measures

Name	Time	Method
Measured using a review of patient records:<br>1. Procedural endpoints [at the end of the index procedure (12 months)]<br>1.1. Device success, lesion success, procedural success<br>2. Safety and efficacy endpoints [30 days and 12 months]<br>2.1. Overall stent thrombosis<br>2.2. All deaths (cardiac, vascular and non-cardiovascular)<br>2.3. Any myocardial infarction (Q wave and non-Q wave MI)<br>2.4. Any repeat revascularization (target lesion and target vessel revascularization)<br>2.5. Target Lesion Failure (TLF)<br>2.6. Target Vessel Failure (TVF): a composite endpoint of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization