The Valentines Trial

NCT01066832 | Completed Phase 4

• 1 other identifier: Eur-001
• Study Type: interventional
• Target: 276
• Locations: 3 countries
• Sites: 3

Brief Summary

The primary objective of this multi-center, international, short term registry is to assess clinical success and efficacy of the paclitaxel eluting balloon treatment for in-stent restenosis at 6-9 months follow up. Clinical success defined as freedom from major adverse cardiac events (MACE: death, myocardial infarction \[MI\], target lesion revascularization \[TLR\]) and target vessel revascularization \[TVR\]) and stent thrombosis, both early and late occurrences will be assessed. In addition, a cohort of the registry will undergo angiographic follow up at 6-9 months to assess in-stent and in-segment late loss and binary restenosis subsequent to paclitaxel eluting balloon treatment for in-stent restenosis. A prioi analysis will be comparison of the safety and efficacy of patients presenting with drug-eluting stent in-stent restenosis to bare metal stent in-stent restenosis.

Conditions

Instent Restenosis

Keywords

Drug-eluting balloon; Paclitaxel; DIOR; short term registry; Valentines Trial; Drug-eluting balloon treatment of in-stent restenosis

Outcome Measures

Primary Outcomes (1)

• Clinical success at 6-9 month defined as freedom from MACE, death, MI,TLR and stent thrombosis

  6-9 month

Secondary Outcomes (1)

• In-stent and in-segment late loss and binary restenosis

  6-9 month

Interventions

Paclitaxel DRUG

Paclitaxel-coated balloon (3 µg/mm2)

Eligibility Criteria

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

You may qualify if:

• Patients, male or female, \> 18 years of age;
• Patients who present with in-stent restenosis of a previously placed stent documented by coronary angiogram for which re-PCI is planned;
• The patient has stable or unstable angina, and/or clinical evidence of ischemia (ECG, exercise test, etc.);
• The target lesion is in a native vessel;
• Up to two lesions per patient;
• Target lesion(s) stenosis is \> 50%.

You may not qualify if:

• The patient has had an acute myocardial infarction within the last 48 hours;
• The patient has a co-morbid illness (i.e. any illness likely to limit his/her life expectancy to \<12 months);
• Lesion(s) requiring additional stenting either bare metal or drug eluting (non, bail-out indications);
• The patient has had previous therapeutic radiation to the target vessel;
• The patient is unable the take dual antiplatelet therapy for at least 6 months;
• Patients with three or more lesions with in-stent restenosis requiring angioplasty.

Sponsors & Collaborators

• Eurocor GmbH: lead

Study Sites (3)

Heart Center Munich at the Isar

Munich, Germany

Location

Policlinico

Modena, Italy

Location

UMC Utrecht

Utrecht, Netherlands

Location

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Pieter Stella, MD, PhD

  UMC Utrecht, Utrecht, Netherlands

  PRINCIPAL INVESTIGATOR

• Sigmund Silber, Prof.

  Heart Center Munich at the Isar, Munich, Germany

  PRINCIPAL INVESTIGATOR

• Giuseppe Sangiorgi, MD

  Policlinico Modena, Modena, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 10, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: June 17, 2011

Record last verified: 2010-02

Locations

NL (1); DE (1); IT (1)